Merck Announces Second-Quarter 2013 Financial Results

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July 30, 2013 6:00 am ET

  • 2013 Second-Quarter Non-GAAP EPS of $0.84, Excluding Certain Items; GAAP EPS of $0.30
  • Worldwide Sales were $11.0 Billion, a Decrease of 11 Percent Reflecting the Unfavorable Impact of Patent Expiries and a 3 Percent Negative Impact from Foreign Exchange Partially Offset by Global Performance of Human Health Products
  • Growth in Key Franchises Including Vaccines, Diabetes and Immunology
  • Continued Return of Cash to Shareholders, Including $5 Billion Accelerated Share Repurchase Announced in May
  • Reaffirmed Full-Year Non-GAAP EPS Target of $3.45 to $3.55, Excluding Certain Items; Revised GAAP EPS Range to $1.84 to $2.05

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the second quarter of 2013.

     
$ in millions, except EPS amounts  

Second
Quarter
2013

 

Second
Quarter
2012

Sales   $11,010   $12,311
GAAP EPS   0.30   0.58

Non-GAAP EPS that excludes items listed below1

  0.84   1.05

GAAP Net Income2

  906   1,793
Non-GAAP Net Income that excludes items listed below1,2   2,530   3,227

Non-GAAP (generally accepted accounting principles) earnings per share (EPS) for the second quarter of $0.84 exclude acquisition-related costs, restructuring costs and certain other items.

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

     

$ in millions, except EPS amounts

  Second Quarter
    2013   2012
EPS        
GAAP EPS   $0.30   $0.58

Difference3

  0.54   0.47
Non-GAAP EPS that excludes items listed below1   $0.84   $1.05
         
Net Income        
GAAP net income2   $906   $1,793
Difference   1,624   1,434
Non-GAAP net income that excludes items listed below1,2   $2,530   $3,227
         
Decrease (Increase) in Net Income Due to Excluded Items:        

Acquisition-related costs4

  $1,768   $1,417
Restructuring costs   278   289
Other   (13)  
Net decrease (increase) in income before taxes   2,033   1,706
Estimated income tax (benefit) expense   (409)   (272)
Decrease (increase) in net income   $1,624   $1,434

“With seven of our top 10 products growing in the second quarter and solid performance overall, we continue to navigate significant patent expiries and adapt to the evolving global healthcare environment,” said Kenneth C. Frazier, chairman and chief executive officer, Merck. “We remain committed to pursuing innovative, best-in-class science that translates into medically important products, such as our PD-1 inhibitor for oncology. To enable further investment in promising growth opportunities, we continue to manage costs effectively, as reflected in our results for the quarter.”

Select Revenue Highlights

Worldwide sales were $11.0 billion for the second quarter of 2013, a decrease of 11 percent compared with the second quarter of 2012, including a 3 percent negative effect from foreign exchange.

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

                     

$ in millions

 

Second
Quarter
2013

 

Second
Quarter
2012

 

Change

     

Change
Ex-
exchange

Total Sales   $11,010   $12,311   -11%       -8%
Pharmaceutical   9,310   10,560   -12%       -9%
JANUVIA   1,072   1,058   1%       7%
ZETIA   650   632   3%       6%
REMICADE   527   518   2%       3%
JANUMET   474   411   16%       17%
VYTORIN   417   445   -6%       -5%
ISENTRESS   412   398   4%       5%
GARDASIL   383   324   18%       19%
PROQUAD, M-M-R II and VARIVAX   339   316   7%       7%
NASONEX   325   293   11%       13%
SINGULAIR   281   1,431   -80%       -79%
Animal Health   851   865   -2%       1%
Consumer Care   490   552   -11%       -10%
Other Revenues   359   333   8%       2%

Pharmaceutical Revenue Performance

Second-quarter pharmaceutical sales declined 12 percent to $9.3 billion, including a 3 percent negative impact due to foreign exchange. Declines of SINGULAIR (montelukast sodium), MAXALT (rizatriptan benzoate), COZAAR (losartan potassium)/HYZAAR (losartan potassium/hydrochlorothiazide) and CLARINEX (desloratadine) following loss of market exclusivity were partially offset by growth of JANUVIA (sitagliptin)/JANUMET (sitagliptin/metformin HCI), GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] and SIMPONI (golimumab).

Sales from emerging markets increased 7 percent, including a 3 percent negative impact from foreign exchange. Emerging market sales accounted for approximately 22 percent of pharmaceutical sales in the second quarter of 2013. China continues to be a key driver of growth in the emerging markets with sales increasing 13 percent for the second quarter, including a 3 percent benefit from foreign exchange.

Worldwide sales of the combined diabetes franchise of JANUVIA/JANUMET increased 5 percent to $1.5 billion in the second quarter, including a 5 percent negative impact from foreign exchange. Sales growth in all regions was partially offset by a decline in Japan due to foreign exchange.

Sales of ZETIA (ezetimibe) and VYTORIN (ezetimibe/simvastatin), medicines for lowering LDL cholesterol, decreased 1 percent to $1.1 billion in the second quarter, including a 2 percent negative impact from foreign exchange. The decrease reflects lower sales of VYTORIN, partially offset by growth of ZETIA mainly in the United States.

Combined sales of REMICADE (infliximab) and SIMPONI, treatments for inflammatory diseases, increased 9 percent, including a 2 percent negative impact from foreign exchange, to $647 million in the second quarter of 2013 primarily reflecting growth of SIMPONI in Europe. Sales of SIMPONI grew 59 percent to $120 million in the quarter.

ISENTRESS (raltegravir), an HIV integrase inhibitor for use in combination with other antiretroviral agents for the treatment of HIV-1 infection, grew 4 percent to $412 million in the second quarter driven by growth in the United States and Europe, partially offset by tenders in Brazil in 2012.

Merck’s sales of GARDASIL, a vaccine to help prevent certain diseases caused by four types of human papillomavirus (HPV), were $383 million, an increase of 18 percent for the quarter. The increase was driven by higher sales in the United States, which reflects continued strong uptake in males, as well as tenders in Latin America in 2013.

Worldwide sales of SINGULAIR, a once-a-day oral medicine for the chronic treatment of asthma and the relief of symptoms of allergic rhinitis, declined 80 percent to $281 million in the second quarter. The patents for SINGULAIR expired in the United States in August 2012 and expired in major European markets in February 2013. The company experienced a significant and rapid reduction in sales in the United States and is now also experiencing a substantial decline in Europe.

Animal Health Revenue Performance

Animal Health sales totaled $851 million for the second quarter of 2013, a 2 percent decline compared with the second quarter of 2012, including a 3 percent negative impact due to foreign exchange. Growth in poultry and companion animal products was partially offset by lower sales of swine products.

Consumer Care Revenue Performance

Second-quarter global sales of Consumer Care were $490 million, a decrease of 11 percent compared to the second quarter of 2012, including a 1 percent negative impact due to foreign exchange. The sales decrease resulted from the ongoing termination in China of certain Consumer Care distribution arrangements and a reversal of sales previously made to those distributors, together with associated termination costs. Excluding those actions, Consumer Care global sales would have increased by 2 percent, including the 1 percent negative impact due to foreign exchange.

Other Revenue Performance

Other revenues – primarily comprising alliance revenue, miscellaneous corporate revenues and third-party manufacturing sales – increased 8 percent to $359 million compared to the second quarter of 2012. The increase was primarily driven by higher revenue from AstraZeneca LP (AZLP) recorded by Merck, which increased 10 percent to $245 million as compared with atypically lower second quarter 2012 AZLP revenues.

Second-Quarter Expense and Other Information

The costs detailed below totaled $9.7 billion on a GAAP basis during the second quarter of 2013 and include $2.0 billion of acquisition-related costs and restructuring costs.

     
$ in millions   Included in expenses for the period

Second Quarter
2013

 

GAAP

 

Acquisition-
Related
Costs4

 

Restructuring
Costs

 

Non-GAAP1

Materials and production   $4,284   $1,515   $93   $2,676
Marketing and administrative   3,140   19   16   3,105
Research and development   2,101   234   14   1,853
Restructuring costs   155   –-   155   –-
                 

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   –-

The gross margin was 61.1 percent for the second quarter of 2013 and 66.6 percent for the second quarter of 2012, reflecting 14.6 and 10.6 percentage point unfavorable impacts, respectively, from the acquisition-related costs and restructuring costs noted above. The gross margin decline, on a non-GAAP basis, primarily reflects the impact of the SINGULAIR patent expiries.

Marketing and administrative expenses, on a non-GAAP basis, were $3.1 billion in the second quarter of 2013, a decrease from $3.2 billion in the second quarter of 2012 due to targeted reductions in spending and productivity improvements.

Research and development (R&D) expenses, on a non-GAAP basis, were $1.9 billion in the second quarter of 2013, a decrease from $2.0 billion in the second quarter of 2012 reflecting lower upfront payments from external licensing activity.

Equity income from affiliates was $116 million for the second quarter, primarily reflecting the performance of partnerships with AZLP and Sanofi Pasteur MSD.

Other (income) expense, net was $201 million of expense in the second quarter of 2013, compared to $103 million of expense in the second quarter of 2012.

The company noted the following developments:

  • Presented at the American Society of Clinical Oncology in Chicago preliminary results from an ongoing Phase IB expansion study evaluating the safety and efficacy of MK-3475, Merck’s investigational antibody therapy targeting PD-1, in patients with advanced (inoperable and metastatic) melanoma.
  • Announced an accelerated share repurchase agreement (ASR) to repurchase $5 billion of Merck’s common stock, which is part of Merck’s previously announced $15 billion share repurchase program. Proceeds from the company’s $6.5 billion debt offering were used to execute the ASR.
  • Announced that the U.S. Food and Drug Administration (FDA) has approved LIPTRUZET (ezetimibe and atorvastatin) tablets for the treatment of elevated low-density lipoprotein (LDL) cholesterol in patients with primary or mixed hyperlipidemia as adjunctive therapy to diet when diet alone is not enough.
  • Advised by the FDA that the agency needs additional time to assess the results of a recently completed inspection of a clinical trial site for sugammadex, Merck’s investigational medicine for the reversal of neuromuscular blockade induced by rocuronium or vecuronium.
  • Received a Complete Response Letter from the FDA regarding the New Drug Application for suvorexant, Merck’s investigational medicine for the treatment of insomnia. The company is evaluating the requests outlined in the Complete Response Letter, and plans to submit definitive data in response to the FDA in the first half of 2014.

Financial Targets

Merck reiterated that it expects full-year 2013 non-GAAP EPS to be between $3.45 and $3.55, and revised 2013 GAAP EPS to be between $1.84 and $2.05. The 2013 non-GAAP range excludes acquisition-related costs, costs related to restructuring programs and certain other items.

At current exchange rates, Merck now expects full-year 2013 sales to be approximately 5 to 6 percent below prior year levels with foreign exchange accounting for approximately 3 percentage points of the decline.

In addition, the company now expects full-year 2013 non-GAAP R&D expense to be below 2012 levels. The company continues to expect its full-year 2013 non-GAAP tax rate to be in the range of 22 to 23 percent.

A reconciliation of anticipated 2013 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 2013
GAAP EPS     $1.84 to $2.05
Difference3     1.61 to 1.50
Non-GAAP EPS that excludes items listed below     $3.45 to $3.55
       
       
Acquisition-related costs     $5,400 to $5,200
Restructuring costs     700 to 500
Net decrease (increase) in income before taxes     6,100 to 5,700
Estimated income tax (benefit) expense     (1,275) to (1,195)
Decrease (increase) in net income     $4,825 to $4,505

Total Employees

As of June 30, 2013, Merck had approximately 81,000 employees worldwide. In addition, the company’s joint ventures in China and Brazil, which are included in the consolidated results of Merck, had about 1,300 employees.

Earnings Conference Call

Investors, journalists and the general public may access a live audio webcast of the call today at 8:00 a.m. EDT on Merck’s website at http://www.merck.com/investors/events-and-presentations/home.html. Institutional investors and analysts can participate in the call by dialing (706) 758-9927 or (877) 381-5782 and using ID code number 77194196. Members of the media are invited to monitor the call by dialing (706) 758-9928 or (800) 399-7917 and using ID code number 77194196. Journalists who wish to ask questions are requested to contact a member of Merck’s Media Relations team at the conclusion of the call.

About Merck

Today’s Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching 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. These statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

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

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

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

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

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

4 Includes expenses for the amortization of intangible assets recognized as a result of mergers and acquisitions of $1.2 billion in both the second quarter of 2013 and the second quarter of 2012, as well as intangible asset impairment charges of $564 million and $127 million in the second quarter of 2013 and 2012, respectively. Also includes integration and other costs associated with mergers and acquisitions.

MERCK & CO., INC.
CONSOLIDATED STATEMENT OF OPERATIONS – GAAP
(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)
(UNAUDITED)
Table 1
                 
    GAAP   % Change   GAAP   % Change
    2Q13   2Q12     YTD 2013   YTD 2012  
Sales   $ 11,010     $ 12,311     -11 %   $ 21,681     $ 24,041     -10 %
                         
Costs, Expenses and Other                        
Materials and production (1)     4,284       4,112     4 %     8,243       8,150     1 %
Marketing and administrative (1)     3,140       3,249     -3 %     6,126       6,322     -3 %
Research and development (1)     2,101       2,165     -3 %     4,008       4,026      
Restructuring costs (2)     155       144     8 %     274       363     -25 %
Equity income from affiliates (3)     (116 )     (142 )   -18 %     (249 )     (253 )   -2 %
Other (income) expense, net (1) / (4)     201       103     95 %     484       247     96 %
                         
Income Before Taxes     1,245       2,680     -54 %     2,795       5,186     -46 %
Income Tax Provision     310       860           244       1,599      
Net Income     935       1,820     -49 %     2,551       3,587     -29 %
Less: Net Income Attributable to Noncontrolling Interests     29       27           52       56      
Net Income Attributable to Merck & Co., Inc.   $ 906     $ 1,793     -49 %   $ 2,499     $ 3,531     -29 %
Earnings per Common Share Assuming Dilution   $ 0.30     $ 0.58     -48 %   $ 0.82     $ 1.15     -29 %
                         
Average Shares Outstanding Assuming Dilution     3,010       3,072           3,030       3,074      
Tax Rate (5)     24.9 %     32.1 %         8.7 %     30.8 %    
(1) Amounts include the impact of acquisition-related costs, restructuring costs and certain other items. See accompanying tables for details.
 
(2) Represents separation and other related costs associated with restructuring activities under the company’s formal restructuring programs.
 
(3) Primarily reflects equity income from the AstraZeneca LP and Sanofi Pasteur MSD partnerships.
 
(4) Other (income) expense, net in the second quarter and first six months of 2013 reflects higher exchange losses, which for the first six months of 2013 includes approximately $140 million as a result of a Venezuelan currency devaluation.
 
(5) The effective tax rates for the second quarter and first six months of 2013 reflect benefits from reductions in tax reserves upon expiration of applicable statute of limitations. In addition, the effective tax rate for the first six months of 2013 reflects the favorable impact of tax legislation enacted in the first quarter of 2013, as well as a benefit of approximately $160 million associated with the resolution of a previously disclosed legacy Schering-Plough federal income tax issue.
 
 
MERCK & CO., INC.
CONSOLIDATED STATEMENT OF OPERATIONS – GAAP
(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)
(UNAUDITED)
Table 1a
             
    2013   2012   % Change
    1Q   2Q   YTD   1Q   2Q   YTD   3Q   4Q   Full Year   2Q   YTD
   

 

                                       
Sales   $ 10,671     $ 11,010     $ 21,681     $ 11,731     $ 12,311     $ 24,041     $ 11,488     $ 11,738     $ 47,267     -11 %   -10 %
                                             
Costs, Expenses and Other                                            
Materials and production     3,959       4,284       8,243       4,037       4,112       8,150       4,137       4,160       16,446     4 %   1 %
Marketing and administrative     2,987       3,140       6,126       3,074       3,249       6,322       3,063       3,390       12,776     -3 %   -3 %
Research and development     1,907       2,101       4,008       1,862       2,165       4,026       1,918       2,224       8,168     -3 %    
Restructuring costs     119       155       274       219       144       363       110       191       664     8 %   -25 %
Equity income from affiliates     (133 )     (116 )     (249 )     (110 )     (142 )     (253 )     (158 )     (231 )     (642 )   -18 %   -2 %
Other (income) expense, net     282       201       484       142       103       247       200       669       1,116     95 %   96 %
                                             
Income Before Taxes     1,550       1,245       2,795       2,507       2,680       5,186       2,218       1,335       8,739     -54 %   -46 %
Income Tax Provision (Benefit)     (66 )     310       244       740       860       1,599       455       385       2,440          
Net Income     1,616       935       2,551       1,767       1,820       3,587       1,763       950       6,299     -49 %   -29 %
Less: Net Income Attributable to Noncontrolling Interests     23       29       52       29       27       56       34       42       131          
Net Income Attributable to Merck & Co., Inc.   $ 1,593     $ 906     $ 2,499     $ 1,738     $ 1,793     $ 3,531     $ 1,729     $ 908     $ 6,168     -49 %   -29 %
Earnings per Common Share Assuming Dilution   $ 0.52     $ 0.30     $ 0.82     $ 0.56     $ 0.58     $ 1.15     $ 0.56     $ 0.30     $ 2.00     -48 %   -29 %
                 
Average Shares Outstanding Assuming Dilution     3,053       3,010       3,030       3,074       3,072       3,074       3,079       3,074       3,076          
Tax Rate     -4.3 %     24.9 %     8.7 %     29.5 %     32.1 %     30.8 %     20.5 %     28.8 %     27.9 %        
                                             
Sum of quarterly amounts may not equal year-to-date amounts due to rounding.
MERCK & CO., INC.
CONSOLIDATED STATEMENT OF OPERATIONS
GAAP TO NON-GAAP RECONCILIATION
SECOND QUARTER 2013
(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)
(UNAUDITED)
Table 2a
                         
    GAAP  

Acquisition-
Related Costs (1)

 

Restructuring
Costs (2)

 

Certain Other
Items

 

Adjustment
Subtotal

  Non-GAAP
                         
Sales   $ 11,010                     $ 11,010  
                         
Costs, Expenses and Other                        
Materials and production     4,284     1,515     93           1,608       2,676  
Marketing and administrative     3,140     19     16           35       3,105  
Research and development     2,101     234     14           248       1,853  
Restructuring costs     155         155           155        
Equity income from affiliates     (116 )                       (116 )
Other (income) expense, net     201             (13 )     (13 )     214  
Income Before Taxes     1,245     (1,768 )   (278 )   13       (2,033 )     3,278  
Taxes on Income     310                   (409

)(3)

    719  
Net Income     935                   (1,624 )     2,559  
Less: Net Income Attributable to Noncontrolling Interests     29                         29  
Net Income Attributable to Merck & Co., Inc.   $ 906                 $ (1,624 )   $ 2,530  
Earnings per Common Share Assuming Dilution   $ 0.30                     $ 0.84  
                         
Average Shares Outstanding Assuming Dilution     3,010                       3,010  
Tax Rate     24.9 %                     21.9 %
Merck is providing non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing this information enhances investors’ understanding of the company’s performance. This information should be considered in addition to, but not in lieu of, information prepared in accordance with GAAP.
   
(1) Amounts included in materials and production costs reflect expenses of $1.2 billion for the amortization of intangible assets recognized as a result of mergers and acquisitions, as well as $330 million of impairment charges on product intangibles. Amounts included in marketing and administrative expenses reflect merger integration costs. Amounts included in research and development expenses represent in-process research and development (“IPR&D”) impairment charges.
   
(2) Amounts primarily include employee separation costs and accelerated depreciation associated with facilities to be closed or divested related to actions under the company’s formal restructuring programs.
   
(3) Represents the estimated tax impact on the reconciling items.
 
 
 
 
MERCK & CO., INC.
CONSOLIDATED STATEMENT OF OPERATIONS
GAAP TO NON-GAAP RECONCILIATION
SIX MONTHS ENDED JUNE 30, 2013
(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)
(UNAUDITED)
Table 2b
                         
    GAAP  

Acquisition-
Related Costs (1)

 

Restructuring
Costs (2)

 

Certain Other
Items

 

Adjustment
Subtotal

  Non-GAAP
                         
Sales   $ 21,681                     $ 21,681  
                         
Costs, Expenses and Other                        
Materials and production     8,243     2,699     136           2,835       5,408  
Marketing and administrative     6,126     42     33           75       6,051  
Research and development     4,008     264     29           293       3,715  
Restructuring costs     274         274           274        
Equity income from affiliates     (249 )                       (249 )
Other (income) expense, net     484             (13 )     (13 )     497  
Income Before Taxes     2,795     (3,005 )   (472 )   13       (3,464 )     6,259  
Taxes on Income     244                  

(848

)(3)

    1,092  
Net Income     2,551                   (2,616 )     5,167  
Less: Net Income Attributable to Noncontrolling Interests     52                         52  
Net Income Attributable to Merck & Co., Inc.   $ 2,499                 $ (2,616 )   $ 5,115  
Earnings per Common Share Assuming Dilution   $ 0.82                     $ 1.69  
                         
Average Shares Outstanding Assuming Dilution     3,030                       3,030  
Tax Rate     8.7 %                     17.4 %
Merck is providing non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing this information enhances investors’ understanding of the company’s performance. This information should be considered in addition to, but not in lieu of, information prepared in accordance with GAAP.
   
(1) Amounts included in materials and production costs reflect expenses of $2.4 billion for the amortization of intangible assets recognized as a result of mergers and acquisitions, as well as $330 million of impairment charges on product intangibles. Amounts included in marketing and administrative expenses reflect merger integration costs. Amounts included in research and development expenses represent in-process research and development (“IPR&D”) impairment charges.
   
(2) Amounts primarily include employee separation costs and accelerated depreciation associated with facilities to be closed or divested related to actions under the company’s formal restructuring programs.
   
(3) Represents the estimated tax impact on the reconciling items, as well as a benefit of approximately $160 million associated with the resolution of a previously disclosed legacy Schering-Plough federal income tax issue.
 
 
MERCK & CO., INC.
CONSOLIDATED STATEMENT OF OPERATIONS
GAAP TO NON-GAAP RECONCILIATION
SECOND QUARTER 2012
(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)
(UNAUDITED)
Table 2c
                     
   

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  
                     
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.
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 2d
                     
    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  
                     
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.
     
     
MERCK & CO., INC.
FRANCHISE / KEY PRODUCT SALES
(AMOUNTS IN MILLIONS)
Table 3
                 
    2013   2012   % Change   % Change
            Jun YTD           Jun YTD           Full Year    
    1Q   2Q     1Q   2Q     3Q   4Q     2Q   Jun YTD
                                             
TOTAL SALES (1)   $10,671   $11,010   $21,681   $11,731   $12,311   $24,041   $11,488   $11,738   $47,267   -11   -10
PHARMACEUTICAL   8,891   9,310   18,201   10,082   10,560   20,642   9,875   10,085   40,601   -12   -12
                                             
Primary Care and Women’s Health                                        
Cardiovascular                                            
Zetia   629   650   1,279   614   632   1,246   645   676   2,567   3   3
Vytorin   394   417   810   444   445   889   423   435   1,747   -6   -9
                                             
Diabetes & Obesity                                            
Januvia   884   1,072   1,956   919   1,058   1,977   975   1,134   4,086   1   -1
Janumet   409   474   883   392   411   802   405   452   1,659   16   10
                                             
Respiratory                                            
Nasonex   385   325   711   375   293   668   292   308   1,268   11   6
Singulair   337   281   618   1,340   1,431   2,771   602   480   3,853   -80   -78
Dulera   68   79   147   39   50   89   52   67   207   57   66
Asmanex   40   49   89   48   51   99   42   44   185   -3   -9
                                             
Women’s Health & Endocrine                                            
NuvaRing   151   171   322   146   157   303   156   164   623   9   6
Fosamax   137   144   281   184   186   370   152   154   676   -22   -24
Follistim AQ   122   134   257   116   125   241   111   116   468   8   6
Implanon   84   102   187   76   85   161   93   94   348   20   16
Cerazette   61   48   108   67   72   139   64   68   271   -34   -22
                                             
Other                                            
Arcoxia   121   121   242   112   117   229   109   115   453   4   6
Avelox   36   29   65   73   44   117   30   55   201   -34   -45
                                             
Hospital and Specialty                                            
                                             
Immunology                                            
Remicade   549   527   1,076   519   518   1,037   490   549   2,076   2   4
Simponi   108   120   228   74   76   150   86   95   331   59   52
                                             
Infectious Disease                                            
Isentress   362   412   775   337   398   735   399   381   1,515   4   5
Cancidas   162   163   326   145   166   311   163   145   619   -1   5
PegIntron   126   142   268   162   183   345   165   143   653   -22   -22
Invanz   110   120   230   101   110   211   118   116   445   9   9
Victrelis   110   116   226   111   126   238   149   115   502   -8   -5
Noxafil   65   71   136   59   66   125   66   68   258   7   9
                                             
Oncology                                            
Temodar   216   219   434   237   225   461   227   229   917   -3   -6
Emend   116   135   250   102   145   247   111   131   489   -7   1
                                             
Other                                            
Cosopt / Trusopt   105   103   209   124   105   229   102   113   444   -2   -9
Bridion   63   69   131   58   60   118   68   75   261   14   11
Integrilin   47   48   95   53   60   113   48   51   211   -20   -15
                                             
Diversified Brands                                            
Cozaar / Hyzaar   267   255   522   336   337   674   295   315   1,284   -24   -23
Primaxin   84   85   168   88   104   192   109   83   384   -19   -12
Zocor   82   74   156   103   96   199   86   98   383   -23   -22
Propecia   68   67   135   108   100   208   104   112   424   -33   -35
Clarinex   61   64   125   134   140   273   64   56   393   -54   -54
Claritin Rx   76   40   115   87   48   134   47   63   244   -17   -14
Remeron   52   53   106   57   66   123   52   57   232   -19   -14
Proscar   39   58   98   51   55   106   55   56   217   7   -8
Maxalt   40   43   83   156   154   310   166   162   638   -72   -73
                                             
Vaccines                                            
Gardasil   390   383   773   284   324   608   581   442   1,631   18   27
ProQuad, M-M-R II and Varivax   272   339   611   255   316   571   396   306   1,273   7   7
Zostavax   168   141   309   76   148   224   202   225   651   -5   38
RotaTeq   162   144   306   142   142   284   150   168   601   1   8
Pneumovax   111   108   219   112   101   213   160   208   580   7   3
                                             
Other Pharmaceutical (2)   1,022   1,115   2,136   1,066   1,034   2,102   1,065   1,161   4,333   8   2
                                             
ANIMAL HEALTH   840   851   1,691   821   865   1,686   815   898   3,399   -2  
                                             
CONSUMER CARE (3)   571   490   1,061   554   552   1,106   451   395   1,952   -11   -4
Claritin OTC   177   78   256   169   145   314   118   100   532   -46   -19
                                             
Other Revenues (4)   369   359   727   274   333   608   347   360   1,315   8   20
Astra   262   245   507   186   223   409   255   251   915   10   24
                                             
* 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 $53 million and $86 million for the first and second quarters of 2013. Other Vaccines sales included in Other Pharmaceutical were $60 million, $75 million, $116 million, and $69 million for the first, second, third, and fourth quarters of 2012, respectively.

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

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

 
 
MERCK & CO., INC.
FRANCHISE / KEY PRODUCT SALES
SECOND QUARTER 2013
(AMOUNTS IN MILLIONS)
Table 3a
             
    Global   U.S.   International
    2Q13   2Q12   % Change   2Q13   2Q12   % Change   2Q13   2Q12   % Change
                                     
TOTAL SALES (1)   $11,010   $12,311   -11   $4,608   $5,555   -17   $6,402   $6,756   -5
PHARMACEUTICAL   9,310   10,560   -12   3,689   4,633   -20   5,622   5,927   -5
                                     
Primary Care and Women’s Health                                    
                                     
Cardiovascular                                    
Zetia   650   632   3   351   330   6   299   301   -1
Vytorin   417   445   -6   170   195   -13   247   250   -1
                                     
Diabetes & Obesity                                    
Januvia   1,072   1,058   1   571   532   7   501   525   -5
Janumet   474   411   16   235   210   12   239   201   19
                                     
Respiratory                                    
Nasonex   325   293   11   177   141   25   148   152   -3
Singulair   281   1,431   -80   15   1,002   -99   266   429   -38
Dulera   79   50   57   75   48   57   4   3   62
Asmanex   49   51   -3   44   46   -4   5   5   4
                                     
Women’s Health & Endocrine                                    
NuvaRing   171   157   9   107   92   17   64   65   -2
Fosamax   144   186   -22   4   9   -49   140   177   -21
Follistim AQ   134   125   8   62   47   32   73   78   -7
Implanon   102   85   20   51   39   31   51   46   10
Cerazette   48   72   -34               48   72   -34
                                     
Other                                    
Arcoxia   121   117   4               121   117   4
Avelox   29   44   -34   27   42   -37   2   2   43
                                     
Hospital and Specialty                                    
                                     
Immunology                                    
Remicade   527   518   2               527   518   2
Simponi   120   76   59               120   76   59
                                     
Infectious Disease                                    
Isentress   412   398   4   218   203   7   195   195    
Cancidas   163   166   -1   8   7   27   155   159   -3
PegIntron   142   183   -22   13   24   -44   129   159   -19
Invanz   120   110   9   61   55   11   59   55   6
Victrelis   116   126   -8   52   68   -24   64   58   11
Noxafil   71   66   7   22   21   4   49   45   9
                                     
Oncology                                    
Temodar   219   225   -3   108   106   1   111   119   -6
Emend   135   145   -7   74   73   2   61   73   -17
                                     
Other                                    
Cosopt / Trusopt   103   105   -2   5   4   30   98   101   -3
Bridion   69   60   14               69   60   14
Integrilin   48   60   -20   44   54   -20   4   5   -17
                                     
Diversified Brands                                    
Cozaar / Hyzaar   255   337   -24   5   9   -45   250   329   -24
Primaxin   85   104   -19   4   7   -43   81   97   -17
Zocor   74   96   -23   6   7   -13   68   89   -24
Propecia   67   100   -33   5   33   -84   62   68   -8
Clarinex   64   140   -54   2   54   -97   63   86   -27
Proscar   58   55   7   1   1   -45   58   53   8
Remeron   53   66   -19   1   1   -23   52   64   -19
Maxalt   43   154   -72   14   115   -88   29   38   -26
Claritin Rx   40   48   -17               40   48   -17
                                     
Vaccines                                    
Gardasil   383   324   18   252   224   13   131   101   30
ProQuad, M-M-R II and Varivax   339   316   7   301   285   6   38   31   23
RotaTeq   144   142   1   98   102   -4   46   40   14
Zostavax   141   148   -5   122   137   -11   19   11   77
Pneumovax 23   108   101   7   80   85   -6   28   16   77
                                     
Other Pharmaceutical (2)   1,115   1,034   8   304   225   35   808   809  
                                     
ANIMAL HEALTH   851   865   -2   219   238   -8   632   628   1
                                     
CONSUMER CARE (3)   490   552   -11   390   383   2   99   169   -41
Claritin OTC   78   145   -46   108   101   7   (29)   45   *
                                     
Other Revenues (4)   359   333   8   310   301   3   48   32   52
Astra   245   223   10   245   223   10            

‘* 100% or greater

(1) Only select products are shown.    

(2) Includes Pharmaceutical products not individually shown above. Other Vaccines sales included in Other Pharmaceutical were $86 million and $75 million on a global basis for second quarter 2013 and 2012, respectively.

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

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

 
 
MERCK & CO., INC.
FRANCHISE / KEY PRODUCT SALES
JUNE YEAR-TO-DATE 2013
(AMOUNTS IN MILLIONS)
Table 3b
             
    Global   U.S.   International
    Jun YTD 13   Jun YTD 12   % Change   Jun YTD 13   Jun YTD 12   % Change   Jun YTD 13   Jun YTD 12   % Change
TOTAL SALES (1)   $21,681   $24,041   -10   $8,823   $10,565   -16   $12,858   $13,477   -5
PHARMACEUTICAL   18,201   20,642   -12   6,945   8,823   -21   11,257   11,819   -5
                                     
Primary Care and Women’s Health                                    
                                     
Cardiovascular                                    
Zetia   1,279   1,246   3   685   639   7   594   607   -2
Vytorin   810   889   -9   326   384   -15   484   505   -4
                                     
Diabetes & Obesity                                    
Januvia   1,956   1,977   -1   1,033   1,025   1   923   952   -3
Janumet   883   802   10   432   412   5   451   391   15
                                     
Respiratory                                    
Nasonex   711   668   6   327   303   8   383   365   5
Singulair   618   2,771   -78   16   1,878   -99   601   892   -33
Dulera   147   89   66   140   85   65   7   4   91
Asmanex   89   99   -9   78   89   -12   11   10   17
                                     
Women’s Health & Endocrine                                    
NuvaRing   322   303   6   197   175   12   125   128   -2
Fosamax   281   370   -24   9   16   -41   271   354   -23
Follistim AQ   257   241   6   103   85   21   154   156   -1
Implanon   187   161   16   94   70   34   93   91   2
Cerazette   108   139   -22               108   139   -22
                                     
Other                                    
Arcoxia   242   229   6               242   229   6
Avelox   65   117   -45   60   112   -46   5   5   2
                                     
Hospital and Specialty                                    
                                     
Immunology                                    
Remicade   1,076   1,037   4               1,076   1,037   4
Simponi   228   150   52               228   150   52
                                     
Infectious Disease                                    
Isentress   775   735   5   405   389   4   370   345   7
Cancidas   326   311   5   15   15   2   311   296   5
PegIntron   268   345   -22   23   56   -60   245   289   -15
Invanz   230   211   9   115   106   8   115   105   10
Victrelis   226   238   -5   88   136   -35   138   102   35
Noxafil   136   125   9   40   36   12   97   89   8
                                     
Oncology                                    
Temodar   434   461   -6   215   211   2   219   251   -13
Emend   250   247   1   140   135   4   110   112   -1
                                     
Other                                    
Cosopt / Trusopt   209   229   -9   9   7   22   200   222   -10
Bridion   131   118   11               131   118   11
Integrilin   95   113   -15   87   103   -16   8   9   -13
                                     
Diversified Brands                                    
Cozaar / Hyzaar   522   674   -23   16   13   16   506   660   -23
Primaxin   168   192   -12   7   11   -33   161   181   -11
Zocor   156   199   -22   12   13   -11   144   186   -22
Propecia   135   208   -35   12   64   -82   124   144   -14
Clarinex   125   273   -54   7   105   -93   118   168   -30
Claritin Rx   115   134   -14               115   134   -14
Remeron   106   123   -14   2   3   -13   103   120   -14
Proscar   98   106   -8   2   2   20   95   104   -8
Maxalt   83   310   -73   23   227   -90   60   82   -26
                                     
Vaccines                                    
Gardasil   773   608   27   499   397   26   273   211   30
ProQuad, M-M-R II and Varivax   611   571   7   547   514   7   64   58   12
Zostavax   309   224   38   274   204   34   35   20   77
RotaTeq   306   284   8   228   209   9   78   74   5
Pneumovax 23   219   213   3   166   158   6   53   55   -4
                                     
Other Pharmaceutical (2)   2,136   2,102   2   513   436   18   1,625   1,669   -3
                                     
ANIMAL HEALTH   1,691   1,686     450   431   4   1,241   1,255   -1
                                     
CONSUMER CARE (3)   1,061   1,106   -4   790   766   3   271   340   -20
Claritin OTC   256   314   -19   254   237   7   2   77   -97
                                     
Other Revenues (4)   727   608   20   638   545   17   89   63   42
Astra   507   409   24   507   409   24            
* 100% or greater
(1) Only select products are shown.

(2) Includes Pharmaceutical products not individually shown above. Other Vaccines sales included in Other Pharmaceutical were $140 million and $134 million on a global basis for June YTD 2013 and 2012, respectively.

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

(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)
(UNAUDITED)
Table 3c
             
    1Q13   2Q13   Jun YTD   1Q12   2Q12   Jun YTD   3Q12   4Q12   Full Year  

%
Change
2Q

 

%
Change
Jun YTD

                                             
TOTAL PHARMACEUTICAL   $8,891   $9,310   $18,201   $10,082   $10,560   $20,642   $9,875   $10,085   $40,601   -12   -12
                                             
United States   3,256   3,689   6,945   4,189   4,633   8,823   4,304   3,915   17,041   -20   -21
% Pharmaceutical Sales   36.6%   39.6%   38.2%   41.6%   43.9%   42.7%   43.6%   38.8%   42.0%        
                                             
Europe (1)   2,465   2,343   4,808   2,558   2,540   5,099   2,210   2,441   9,750   -8   -6
% Pharmaceutical Sales   27.7%   25.2%   26.4%   25.4%   24.1%   24.7%   22.4%   24.2%   24.0%        
                                             
Japan   1,034   948   1,982   1,267   1,199   2,466   1,124   1,388   4,978   -21   -20
% Pharmaceutical Sales   11.6%   10.2%   10.9%   12.6%   11.4%   11.9%   11.4%   13.8%   12.3%        
                                             
Latin America   596   676   1,272   627   668   1,295   715   742   2,752   1   -2
% Pharmaceutical Sales   6.7%   7.3%   7.0%   6.2%   6.3%   6.3%   7.2%   7.4%   6.8%        
                                             
Asia Pacific   822   874   1,696   762   787   1,548   846   864   3,259   11   10
% Pharmaceutical Sales   9.2%   9.4%   9.3%   7.6%   7.4%   7.5%   8.6%   8.6%   8.0%        
China   271   297   568   221   262   484   262   298   1,044   13   17
                                             
Eastern Europe/Middle East Africa   439   479   917   361   441   803   366   416   1,584   8   14
% Pharmaceutical Sales   4.9%   5.1%   5.0%   3.6%   4.2%   3.9%   3.7%   4.1%   3.9%        
                                             
Canada   245   257   502   264   236   500   257   276   1,034   9  
% Pharmaceutical Sales   2.8%   2.8%   2.8%   2.6%   2.2%   2.4%   2.6%   2.7%   2.5%        
                                             
Other   34   45   79   53   56   109   52   42   203   -20   -27
% Pharmaceutical Sales   0.4%   0.5%   0.4%   0.5%   0.5%   0.5%   0.5%   0.4%   0.5%        
                                             
(1) Europe primarily represents all European Union countries and the European Union accession markets.
 
 
MERCK & CO., INC.
SECOND QUARTER 2013
EQUITY INCOME / JV SALES / OTHER (INCOME) EXPENSE – GAAP
(AMOUNTS IN MILLIONS)
(UNAUDITED)
Table 4
 
                                       

EQUITY INCOME FROM AFFILIATES

               
                  2Q13       2Q12     YTD 2013     YTD 2012
          ASTRAZENECA LP      

$

105

 

     

$

140

 

   

$

230

 

   

$

253

 

          Other (1)         11           2         19          
          TOTAL       $ 116         $ 142       $ 249       $ 253  
                                       
          (1) Includes results for Sanofi Pasteur MSD.                            
 
                                       

SANOFI PASTEUR MSD JOINT VENTURE SALES DETAIL
All sales reported here are end-market JV sales, presented on a “NET” basis.

               
                  2Q13       2Q12     YTD 2013     YTD 2012
          GARDASIL       $ 61         $ 60       $ 134       $ 115  
          OTHER VIRAL VACCINES         27           30         56         55  
          ROTATEQ         13           12         27         23  
          HEPATITIS VACCINES         7           8         15         17  
          Other Vaccines         99           119         205         225  
          TOTAL SANOFI PASTEUR MSD SALES       $ 207         $ 229       $ 437       $ 435  
                                       
 
                                       

OTHER (INCOME) EXPENSE, NET

               
                  2Q13       2Q12     YTD 2013     YTD 2012
          INTEREST INCOME       $ (65 )       $ (76 )     $ (122 )     $ (129 )
          INTEREST EXPENSE         201           172         385         346  
          EXCHANGE LOSSES         55           13         267         80  
          Other, net         10           (6 )       (46 )       (50 )
          TOTAL       $ 201         $ 103       $ 484       $ 247  
 

 

Merck & Co., Inc.
Media Contacts:
Kelley Dougherty, 908-423-4291
Steven Cragle, 908-423-3461
or
Investor Contacts:
Carol Ferguson, 908-423-4465
Joe Romanelli, 908-423-5185

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