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--Worldwide Sales Up One Percent to $12.3 Billion, Five Percent Excluding Foreign Exchange; Pharmaceuticals, Animal Health and Consumer Care All Contributed to Growth
--Double-Digit Global Growth for JANUVIA, JANUMET, VICTRELIS, ISENTRESS, GARDASIL and ZOSTAVAX
--On Track for Six Major Filings in 2012-2013, Including Suvorexant and Odanacatib
--Reaffirmed 2012 Full-Year Non-GAAP EPS Target of $3.75 to $3.85, Excluding Certain Items; GAAP EPS Range of $2.04 to $2.30
Merck (MRK), known as MSD outside the United States and Canada,
today announced financial results for the second quarter of 2012.
$ in millions, except EPS amounts Second Second
Quarter Quarter
2012 2011
--------------------------------------------------------- ------- -------
Sales $12,311 $12,151
--------------------------------------------------------- ------- -------
GAAP EPS 0.58 0.65
--------------------------------------------------------- ------- -------
Non-GAAP EPS that excludes items listed below(1) 1.05 0.95
--------------------------------------------------------- ------- -------
GAAP Net Income(2) 1,793 2,024
--------------------------------------------------------- ------- -------
Non-GAAP Net Income that excludes items listed below(1,2) 3,227 2,950
--------------------------------------------------------- ------- -------
Non-GAAP (generally accepted accounting principles) earnings per share
(EPS) for the second quarter of $1.05 exclude acquisition-related costs
and restructuring costs.
A reconciliation of GAAP to non-GAAP net income and EPS is provided in
the tables below. Year-to-date results can be found in the attached
tables.
Second Quarter 2012 Second Quarter 2011
------------------- -------------------
$ in millions, except EPS amounts Net EPS Net EPS
Income(2) Income(2)
-------------------------------------------- --------- ------- --------- -------
GAAP $1,793 $0.58 $2,024 $0.65
-------------------------------------------- --------- ------- --------- -------
Difference 1,434 0.47(3) 926 0.30(3)
-------------------------------------------- --------- ------- --------- -------
Non-GAAP that excludes items listed below(1) $3,227 $1.05 $2,950 $0.95
-------------------------------------------- --------- ------- --------- -------
$ in millions Second Second
Quarter Quarter
2012 2011
---------------------------------------------- -------------- -------
Acquisition-related costs(4) $1,417 $1,440
---------------------------------------------- -------------- -------
Restructuring costs 289 816
---------------------------------------------- -------------- -------
Other - 7
---------------------------------------------- -------------- -------
Net decrease (increase) in income before taxes 1,706 2,263
---------------------------------------------- -------------- -------
Income tax (benefit) expense(5) (272) (1,337)
---------------------------------------------- -------------- -------
Decrease (increase) in net income $1,434 $926
---------------------------------------------- -------------- -------
"This quarter we delivered strong operational performance by focusing on
growth and execution. We achieved top- and bottom-line growth by
advancing our core strategy and maintaining momentum across our
businesses," said Kenneth C. Frazier, chairman and chief executive
officer of Merck. "The company remains focused on translating
cutting-edge science into medically important products. Were seeing
significant progress in the pipeline this year, and we expect six major
filings over the next 18 months, including suvorexant for insomnia and
odanacatib for osteoporosis. This focus on innovation and execution will
drive long-term shareholder value."
Select Revenue Highlights
Worldwide sales were $12.3 billion for the second quarter of 2012, an
increase of 1 percent, or 5 percent excluding foreign exchange, compared
with the second quarter of 2011. Sales also were unfavorably impacted by
the arbitration settlement agreement with Johnson & Johnson discussed
below.
The following table reflects sales of the companys top pharmaceutical
products, as well as total sales of animal health and consumer care
products.
$ in millions Second Quarter Second Quarter Change
2012 2011
-------------------------------- -------------- -------------- ------
Total Sales $12,311 $12,151 1%
-------------------------------- -------------- -------------- ------
Pharmaceutical 10,560 10,360 2%
-------------------------------- -------------- -------------- ------
SINGULAIR 1,431 1,354 6%
-------------------------------- -------------- -------------- ------
JANUVIA 1,058 779 36%
-------------------------------- -------------- -------------- ------
ZETIA 632 592 7%
-------------------------------- -------------- -------------- ------
REMICADE 518 842 -38%
-------------------------------- -------------- -------------- ------
VYTORIN 445 459 -3%
-------------------------------- -------------- -------------- ------
JANUMET 411 321 28%
-------------------------------- -------------- -------------- ------
ISENTRESS 398 337 18%
-------------------------------- -------------- -------------- ------
COZAAR/HYZAAR 337 406 -17%
-------------------------------- -------------- -------------- ------
GARDASIL 324 277 17%
-------------------------------- -------------- -------------- ------
PROQUAD, M-M-R II and VARIVAX 316 291 9%
-------------------------------- -------------- -------------- ------
Animal Health 865 802 8%
-------------------------------- -------------- -------------- ------
Consumer Care 552 541 2%
-------------------------------- -------------- -------------- ------
Other Revenues 333 448 -26%
-------------------------------- -------------- -------------- ------
Pharmaceutical Revenue Performance
Second-quarter pharmaceutical sales grew 2 percent to $10.6 billion,
including a 3 percent negative impact due to foreign exchange. Adjusting
pharmaceutical sales in the second quarter of 2011 to exclude sales of
REMICADE (infliximab) and SIMPONI (golimumab) from the territories
transferred to Johnson & Johnson through the settlement agreement,
pharmaceutical sales would have increased 5 percent in the second
quarter of 2012.(6) The revenue increases largely reflect
strong sales growth for JANUVIA (sitagliptin), VICTRELIS (boceprevir),
JANUMET (sitagliptin/metformin hydrochloride), SINGULAIR (montelukast
sodium), ISENTRESS (raltegravir) and GARDASIL [Human Papillomavirus
Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant]. These
increases were partially offset by expected declines in sales of COZAAR
(losartan potassium) and HYZAAR (losartan potassium and
hydrochlorothiazide) as well as European austerity measures.
Sales from emerging markets accounted for approximately 18 percent of
pharmaceutical sales in the second quarter. Growth in the emerging
markets is being driven by diversified brands and core products like
JANUVIA, JANUMET and ISENTRESS. China continues to be a key driver with
27 percent growth for the second quarter, including a 4 percent benefit
from foreign exchange.
Worldwide sales of the combined diabetes franchise of JANUVIA/JANUMET,
medicines that help lower blood sugar levels in adults with type 2
diabetes, grew 33 percent to $1.5 billion in the second quarter of 2012
driven by growth in all regions.
Worldwide sales of SINGULAIR, a once-a-day oral medicine for the chronic
treatment of asthma and the relief of symptoms of allergic rhinitis,
grew 6 percent to $1.4 billion in the second quarter of 2012. The patent
for SINGULAIR will expire in the U.S. in Aug. 2012 and in major European
markets in Feb. 2013. The company expects a significant and rapid
reduction in sales thereafter in those markets. SINGULAIR will retain
marketing exclusivity in Japan until 2016.
Sales of ZETIA (ezetimibe) and VYTORIN (ezetimibe/simvastatin),
medicines for lowering LDL cholesterol, grew 2 percent to $1.1 billion
in the second quarter driven by growth of ZETIA in the United States and
VYTORIN outside of the United States.
Combined sales of REMICADE and SIMPONI, treatments for inflammatory
diseases, declined 35 percent to $594 million for the second quarter of
2012. In Europe, Russia and Turkey, where Merck retained exclusive
marketing rights, the combined sales of REMICADE and SIMPONI declined 3
percent for the second quarter of 2012, but excluding the impact of
foreign exchange grew 6 percent. In July 2011, the company transferred
exclusive marketing rights for REMICADE and SIMPONI to Johnson & Johnson
in Canada, Central and South America, the Middle East, Africa and Asia
Pacific.
ISENTRESS, an HIV integrase inhibitor for use in combination with other
antiretroviral agents for the treatment of HIV-1 infection, grew 18
percent to $398 million in the second quarter driven by strong growth in
the emerging markets and the United States.
Global sales of Mercks antihypertensive medicines COZAAR and HYZAAR
were down 17 percent to $337 million in the second quarter of 2012 due
to the loss of marketing exclusivity in the United States and major
European markets in 2010.
Sales recorded by Merck for GARDASIL, a vaccine to help prevent certain
diseases caused by four types of human papillomavirus (HPV), increased
17 percent to $324 million for the quarter driven by vaccinations of
males in the United States and the launch in Japan.
Sales of ZOSTAVAX (zoster vaccine live), a vaccine for the prevention of
herpes zoster, grew 22 percent to $148 million in the quarter. The
company continues to increase its promotional efforts for ZOSTAVAX in
the United States.
Sales of VICTRELIS, the companys oral hepatitis C virus NS3/4A protease
inhibitor, were $126 million in the quarter. VICTRELIS is approved in 43
countries and has launched in 23 of those markets.
Animal Health Revenue Performance
Animal Health sales totaled $865 million for the second quarter of 2012,
an 8 percent increase over the second quarter of 2011, including a 6
percent negative impact due to foreign exchange. Animal Health had
strong performance in the United States and Asia Pacific, with growth
led by increased sales of cattle and swine products. The divisions
products include pharmaceutical and vaccine products for the prevention,
treatment and control of disease in all major farm and companion animal
species.
Consumer Care Revenue Performance
Second-quarter global sales of Consumer Care were $552 million, an
increase of 2 percent compared to the second quarter of 2011, including
a 1 percent negative impact due to foreign exchange. The sales increase
was primarily due to MiraLAX, CLARITIN and COPPERTONE.
Other Revenue Performance
Other revenues - primarily comprised of alliance revenue, miscellaneous
corporate revenues and third-party manufacturing sales - declined 26
percent to $333 million. The change was driven largely by lower revenue
from AstraZeneca LP (AZLP) recorded by Merck, which declined 27 percent
to $223 million, as well as by lower third-party manufacturing sales.
Second-Quarter Expense and Other Information
The costs detailed below totaled $9.7 billion on a GAAP basis during the
second quarter of 2012 and include $1.7 billion of acquisition-related
costs and restructuring costs.
$ in millions Included in expenses for the period
-------------------------------------------------------
Second Quarter 2012 GAAP Acquisition- Restructuring Non-GAAP(1)
Related Costs
Costs(4)
---------------------------- ------ --------------- ------------- --------------
Materials and production $4,112 $1,226 $83 $2,803
---------------------------- ------ --------------- ------------- --------------
Marketing and administrative 3,249 64 21 3,164
---------------------------- ------ --------------- ------------- --------------
Research and development 2,165 127 41 1,997
---------------------------- ------ --------------- ------------- --------------
Restructuring costs 144 -- 144 -
---------------------------- ------ --------------- ------------- --------------
Second Quarter 2011
----------------------------
Materials and production $4,284 $1,344 $109 $2,831
---------------------------- ------ --------------- ------------- --------------
Marketing and administrative 3,525 77 23 3,425
---------------------------- ------ --------------- ------------- --------------
Research and development 1,936 19 16 1,901
---------------------------- ------ --------------- ------------- --------------
Restructuring costs 668 - 668 -
---------------------------- ------ --------------- ------------- --------------
The gross margin was 66.6 percent for the second quarter of 2012 and
64.7 percent for the second quarter of 2011, reflecting 10.6 and 12.0
percentage point unfavorable impacts, respectively, from the
acquisition-related costs and restructuring costs noted above.
Marketing and administrative expenses, on a non-GAAP basis, were $3.2
billion in the second quarter of 2012, a decrease from $3.4 billion in
the second quarter of 2011. The decrease was primarily due to ongoing
productivity measures.
Research and development (R&D) expenses, on a non-GAAP basis, were $2.0
billion in the second quarter of 2012, an increase from $1.9 billion in
the second quarter of 2011. The increase primarily reflects the $120
million upfront payment as part of the Endocyte Inc. transaction.
Equity income from affiliates was $142 million for the second quarter,
which primarily reflects the performance of AZLP and Sanofi Pasteur MSD.
Other (income) expense, net was $103 million of expense in the second
quarter of 2012, compared to $121 million of expense in the second
quarter of 2011.
Key Developments
The company noted the following developments:
--
Pivotal Phase III data were presented that showed suvorexant, an
investigational treatment for insomnia, improved patients ability to
fall asleep and stay asleep, achieving significance on 15 of 16
primary endpoints. Merck anticipates filing regulatory applications
for approval by the end of 2012;
--
Primary efficacy outcomes were met in the Phase III trial of
odanacatib, Mercks investigational cathepsin-K inhibitor for
osteoporosis, and Merck announced that the study is being concluded
early. Merck expects to file regulatory applications for approval in
the United States and Europe in the first half of 2013 and Japan in
the third quarter of 2013;
--
Merck continued to advance plans for four additional major regulatory
filings by end of 2013 including: BRIDION (sugammadex), a
neuromuscular blocker reversal agent; V503, a nine-valent vaccine for
HPV; TREDAPTIVE (extended-release niacin/laropiprant), a novel
candidate for multiple lipid parameters; and vintafolide, a small
molecule drug conjugate for ovarian and other cancers (European Union
filing);
--
Merck previously announced in late March 2012 that the independent
Data Safety Monitoring Board of the IMPROVE-IT study planned to review
data from the study again in approximately nine months. That review
has been scheduled for March 2013, at which point nine months of
additional data will have been adjudicated;
--
Five-year data were presented from the STARTMRK study, in which the
regimen including ISENTRESS demonstrated better efficacy and long-term
safety and tolerability versus the regimen including efavirenz; and
--
Merck and AstraZeneca amended their option agreement related to AZLP.
As a result, AstraZeneca will not acquire Mercks stake in AZLP in
2012 and has a new option to acquire Mercks interest in June 2014.
Financial Targets
Merck continues to expect full-year 2012 non-GAAP EPS to be between
$3.75 and $3.85 and the 2012 GAAP EPS range to be $2.04 to $2.30. The
2012 non-GAAP range excludes acquisition-related costs and costs related
to restructuring programs.
Merck continues to expect full-year 2012 revenues to be at or near 2011
levels on a constant currency basis. At current exchange rates, sales
would be affected unfavorably by approximately 6 percent for the third
quarter and more than 3 percent for the full year.
In addition, the company expects full-year 2012 non-GAAP R&D expenses to
be slightly higher than the 2011 level. The company now expects the
full-year 2012 non-GAAP tax rate to be approximately 25 percent.
A reconciliation of anticipated 2012 EPS as reported in accordance with
GAAP to non-GAAP EPS that excludes certain items is provided in the
table below.
$ in millions, except EPS amounts Full-Year 2012
---------------------------------------------- ----------------
GAAP EPS $2.04 to $2.30
---------------------------------------------- ----------------
Difference(3) 1.71 to 1.55
---------------------------------------------- ----------------
Non-GAAP EPS that excludes items listed below $3.75 to $3.85
---------------------------------------------- ----------------
Acquisition-related costs(4) $5,200 to $4,900
---------------------------------------------- ----------------
Restructuring costs 1,100 to 800
---------------------------------------------- ----------------
Net decrease (increase) in income before taxes 6,300 to 5,700
---------------------------------------------- ----------------
Estimated income tax (benefit) expense (1,110) to (985)
---------------------------------------------- ----------------
Decrease (increase) in net income $5,190 to $4,715
---------------------------------------------- ----------------
Total Employees
As of June 30, 2012, Merck had approximately 84,000 employees worldwide.
Earnings Conference Call
Investors are invited to a live audio webcast of Mercks second-quarter
earnings conference call today at 8:00 a.m. EDT by visiting Mercks
Internet site, www.merck.com/investors/events-and-presentations/home.html.
Institutional investors and analysts can participate in the call by
dialing (706) 758-9927 or (877) 381-5782. Journalists are invited to
monitor the call by dialing (706) 758-9928 or (800) 399-7917. A replay
of the call will be available starting at 11 a.m. EDT today for
approximately one week. To listen to the replay, dial (404) 537-3406 or
(855) 859-2056 and enter ID No. 91089609.
About Merck
Todays Merck is a global healthcare leader working to help the world be
well. Merck is known as MSD outside the United States and Canada.
Through our prescription medicines, vaccines, biologic therapies, and
consumer care and animal health products, we work with customers and
operate in more than 140 countries to deliver innovative health
solutions. We also demonstrate our commitment to increasing access to
healthcare through far-reaching policies, programs and partnerships. For
more information, visit www.merck.com
and connect with us on Twitter, Facebook and YouTube.
Forward-Looking Statement
This news release includes "forward-looking statements" within the
meaning of the safe harbor provisions of the United States Private
Securities Litigation Reform Act of 1995. Such statements may include,
but are not limited to, statements about the benefits of the merger
between Merck and Schering-Plough, including future financial and
operating results, the combined companys plans, objectives,
expectations and intentions and other statements that are not historical
facts. Such statements are based upon the current beliefs and
expectations of Mercks management and are subject to significant risks
and uncertainties. Actual results may differ from those set forth in the
forward-looking statements.
The following factors, among others, could cause actual results to
differ from those set forth in the forward-looking statements: the
possibility that all of the expected synergies from the merger of Merck
and Schering-Plough will not be realized, or will not be realized within
the expected time period; the impact of pharmaceutical industry
regulation and health care legislation in the United States and
internationally; Mercks ability to accurately predict future market
conditions; dependence on the effectiveness of Mercks patents and other
protections for innovative products; and the exposure to litigation
and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events or
otherwise. Additional factors that could cause results to differ
materially from those described in the forward-looking statements can be
found in Mercks 2011 Annual Report on Form 10-K and the companys other
filings with the Securities and Exchange Commission (SEC) available at
the SECs Internet site (www.sec.gov).
(1) Merck is providing certain 2012 and 2011 non-GAAP
information that excludes certain items because of the nature of these
items and the impact they have on the analysis of underlying business
performance and trends. Management believes that providing this
information enhances investors understanding of the companys
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.
(3)Represents the difference between calculated GAAP EPS and
calculated non-GAAP EPS which may be different than the amount
calculated by dividing the impact of the excluded items by the weighted
average shares.
(4) Includes expenses for the amortization of intangible assets
and amortization of purchase accounting adjustments to inventories
recognized as a result of mergers and acquisitions, as well as
intangible asset impairment charges. Also includes integration and other
costs associated with mergers and acquisitions.
(5) Includes an estimated income tax (benefit) expense on the
reconciling items. The second quarter of 2011 also includes the net
favorable impact of approximately $700 million relating to the
settlement of a federal income tax audit, as well as the favorable
impact of certain foreign and state tax rate changes that resulted in a
net $230 million reduction of deferred tax liabilities on intangibles
established in purchase accounting.
(6)
$ in millions Second Second Change
Quarter Quarter
2012 2011
------------------------------------------------------------ -------------- ------- ------
Pharmaceutical sales as reported $10,560 $10,360 2%
------------------------------------------------------------ -------------- ------- ------
Sales of REMICADE and SIMPONI in the territories transferred - (306)
------------------------------------------------------------ -------------- -------
Pharmaceutical sales as adjusted $10,560 $10,054 5%
------------------------------------------------------------ -------------- ------- ------
MERCK & CO., INC.
CONSOLIDATED STATEMENT OF
OPERATIONS - GAAP
(AMOUNTS IN MILLIONS, EXCEPT PER
SHARE FIGURES)
(UNAUDITED)
Table 1
GAAP % Change GAAP % Change
----------------------- ---------------------------
2Q12 2Q11 YTD 2012 YTD 2011
----------- ----------- -------- ------------- ------------- --------
Sales $12,311 $12,151 1% $ 24,041 $ 23,732 1%
Costs, Expenses and Other
Materials and production (1) 4,112 4,284 -4% 8,150 8,343 -2%
Marketing and administrative (1) 3,249 3,525 -8% 6,322 6,689 -5%
Research and development (1) 2,165 1,936 12% 4,026 4,094 -2%
Restructuring costs (2) 144 668 -78% 363 654 -44%
Equity income from affiliates (3) (142 ) (55 ) * (253 ) (193 ) 31%
Other (income) expense, net (1) / (4) 103 121 -15% 247 744 -67%
Income Before Taxes 2,680 1,672 60% 5,186 3,401 52%
Income Tax Provision (Benefit) 860 (382 ) 1,599 276
Net Income 1,820 2,054 -11% 3,587 3,125 15%
Less: Net Income Attributable to Noncontrolling Interests 27 30 56 58
Net Income Attributable to Merck & Co., Inc. $ 1,793 $ 2,024 -11% $ 3,531 $ 3,067 15%
Earnings per Common Share Assuming Dilution (5) $ 0.58 $ 0.65 -11% $ 1.15 $ 0.98 17%
- ------ - ------ -------- -- ------ -- ------ --------
Average Shares Outstanding Assuming Dilution 3,072 3,110 3,074 3,106
------ ------
Tax Rate (6) 32.1 % -22.8 % 30.8 % 8.1 %
------ - ------ - ------ -- ------ --
*100% or greater
(1) Amounts include the impact of acquisition-related costs and
restructuring costs. See accompanying tables for details.
(2) Represents separation and other related costs associated with
restructuring activities under the companys formal restructuring
programs.
(3) Primarily reflects equity income from the AstraZeneca LP and
Sanofi Pasteur MSD partnerships.
(4) Other (income) expense, net in the first six months of 2011
includes a charge of $500 million related to the resolution of the
arbitration proceeding with Johnson & Johnson and a $127 million
gain on the sale of certain manufacturing facilities and related
assets.
(5) The company calculates earnings per share pursuant to the
two-class method which requires the allocation of net income between
common shareholders and participating security holders. Net income
attributable to Merck & Co., Inc. common shareholders used to
calculate earnings per common share assuming dilution was $1,792
million and $2,020 million for the second quarter of 2012 and 2011,
respectively, and was $3,528 million and $3,059 million for the
first six months of 2012 and 2011, respectively.
(6) The GAAP effective tax rates for the second quarter and first
six months of 2012 were 32.1% and 30.8%, respectively. Excluding the
impact of the non-GAAP reconciling items detailed in the
accompanying tables, the effective tax rates were 25.8% and 25.3%
for the second quarter and first six months of 2012, respectively.
The GAAP effective tax rates for the second quarter and first six
months of 2011 were (22.8)% and 8.1%, respectively. Excluding the
impact of the non-GAAP reconciling items detailed in the
accompanying tables, the effective tax rates were 24.3% and 24.9%
for the second quarter and first six months of 2011, respectively.
MERCK & CO., INC.
CONSOLIDATED STATEMENT OF
OPERATIONS
GAAP TO NON-GAAP RECONCILIATION
SECOND
QUARTER 2012
(AMOUNTS IN MILLIONS, EXCEPT PER SHARE
FIGURES)
(UNAUDITED)
Table 2a
GAAP Acquisition- Restructuring Adjustment Non-GAAP
Related Costs(1) Costs (2) Subtotal
-------- -------------- ------------ ------------ ----------
Sales $12,311 $ - $ 12,311
Costs, Expenses and Other
Materials and production 4,112 1,226 83 1,309 2,803
Marketing and administrative 3,249 64 21 85 3,164
Research and development 2,165 127 41 168 1,997
Restructuring costs 144 144 144 -
Equity income from affiliates (142 ) - (142 )
Other (income) expense, net 103 - 103
Income Before Taxes 2,680 (1,417 ) (289 ) (1,706 ) 4,386
Taxes on Income 860 (272 ) (3) 1,132
Net Income 1,820 (1,434 ) 3,254
Less: Net Income Attributable to Noncontrolling Interests 27 - 27
Net Income Attributable to Merck & Co., Inc. $ 1,793 $ (1,434 ) $ 3,227
Earnings per Common Share Assuming Dilution $ 0.58 $ 1.05 (4)
- ------ -- ------
Average Shares Outstanding Assuming Dilution 3,072 3,072
Tax Rate 32.1 % 25.8 %
------ - ------ --
Merck is providing non-GAAP information that excludes certain items
because of the nature of these items and the impact they have on the
analysis of underlying business performance and trends. Management
believes that providing this information enhances investors
understanding of the companys 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 companys formal restructuring
programs.
(3) Represents the estimated tax impact on the reconciling items.
(4) The company calculates earnings per share pursuant to the
two-class method which requires the allocation of net income between
common shareholders and participating security holders. Net income
attributable to Merck & Co., Inc. common shareholders used to
calculate non-GAAP earnings per common share assuming dilution was
$3,226 million for the second quarter of 2012.
MERCK & CO., INC.
CONSOLIDATED STATEMENT OF
OPERATIONS
GAAP TO NON-GAAP RECONCILIATION
SIX
MONTHS ENDED JUNE 30, 2012
(AMOUNTS IN MILLIONS,
EXCEPT PER SHARE FIGURES)
(UNAUDITED)
Table
2b
GAAP Acquisition- Restructuring Adjustment Non-GAAP
Related Costs (1) Costs (2) Subtotal
-------- --------------- ------------ ------------ ----------
Sales $24,041 $ - $ 24,041
Costs, Expenses and Other
Materials and production 8,150 2,455 88 2,543 5,607
Marketing and administrative 6,322 115 45 160 6,162
Research and development 4,026 136 86 222 3,804
Restructuring costs 363 363 363 -
Equity income from affiliates (253 ) - (253 )
Other (income) expense, net 247 - 247
Income Before Taxes 5,186 (2,706 ) (582 ) (3,288 ) 8,474
Taxes on Income 1,599 (548 ) (3) 2,147
Net Income 3,587 (2,740 ) 6,327
Less: Net Income Attributable to Noncontrolling Interests 56 - 56
Net Income Attributable to Merck & Co., Inc. $ 3,531 $ (2,740 ) $ 6,271
Earnings per Common Share Assuming Dilution $ 1.15 $ 2.04 (4)
- ------ -- ------
Average Shares Outstanding Assuming Dilution 3,074 3,074
Tax Rate 30.8 % 25.3 %
------ - ------ --
Merck is providing non-GAAP information that excludes certain items
because of the nature of these items and the impact they have on the
analysis of underlying business performance and trends. Management
believes that providing this information enhances investors
understanding of the companys 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 companys formal restructuring
programs.
(3) Represents the estimated tax impact on the reconciling items.
(4) The company calculates earnings per share pursuant to the
two-class method which requires the allocation of net income between
common shareholders and participating security holders. Net income
attributable to Merck & Co., Inc. common shareholders used to
calculate non-GAAP earnings per common share assuming dilution was
$6,266 million for the first six months of 2012.
MERCK & CO., INC.
FRANCHISE / KEY PRODUCT SALES
(AMOUNTS
IN MILLIONS)
Table 3
2012 2011 % Change % Change
1Q 2Q Jun YTD 1Q 2Q Jun YTD 3Q 4Q Full Year 2Q Jun YTD
------- ------- ------- ------- ------- ------- ------- ------- --------- -------- --------
TOTAL SALES (1) $11,731 $12,311 $24,041 $11,580 $12,151 $23,732 $12,022 $12,294 $48,047 1 1
------- ------- ------- ------- ------- ------- ------- ------- --------- -------- --------
PHARMACEUTICAL 10,082 10,560 20,642 9,820 10,360 20,179 10,354 10,755 41,289 2 2
Primary Care and Womens Health
Cardiovascular
Zetia 614 632 1,246 582 592 1,174 614 640 2,428 7 6
Vytorin 444 445 889 480 459 939 469 475 1,882 -3 -5
Diabetes & Obesity
Januvia 919 1,058 1,977 739 779 1,518 846 960 3,324 36 30
Janumet 392 411 802 305 321 626 350 386 1,363 28 28
Respiratory
Singulair 1,340 1,431 2,771 1,328 1,354 2,682 1,336 1,461 5,479 6 3
Nasonex 375 293 668 373 323 696 266 325 1,286 -9 -4
Clarinex 134 140 273 155 209 364 128 129 621 -33 -25
Asmanex 48 51 99 60 47 107 42 57 206 8 -8
Dulera 39 50 89 13 25 37 22 37 96 * *
Womens Health & Endocrine
Fosamax 184 186 370 208 221 429 215 211 855 -16 -14
NuvaRing 146 157 303 142 154 297 159 168 623 2 2
Follistim AQ 116 125 241 133 143 276 129 126 530 -12 -13
Implanon 76 85 161 60 81 141 80 74 294 5 14
Cerazette 67 72 139 59 66 125 74 69 268 9 11
Other
Maxalt 156 154 310 173 131 304 156 178 639 17 2
Arcoxia 112 117 229 114 100 214 108 110 431 17 7
Avelox 73 44 117 106 61 167 59 95 322 -28 -30
Hospital and Specialty
Immunology
Remicade 519 518 1,037 753 842 1,595 561 511 2,667 -38 -35
Simponi 74 76 150 54 75 129 74 61 264 1 16
Infectious Disease
Isentress 337 398 735 292 337 629 343 387 1,359 18 17
PegIntron 162 183 345 166 154 319 163 175 657 19 8
Cancidas 145 166 311 158 168 326 150 164 640 -1 -4
Victrelis 111 126 238 1 21 22 31 87 140 * *
Invanz 101 110 211 87 103 189 107 110 406 7 12
Primaxin 88 104 192 136 136 272 124 119 515 -24 -30
Noxafil 59 66 125 55 56 110 61 59 230 19 13
Oncology
Temodar 237 225 461 248 234 481 223 230 935 -4 -4
Emend 102 145 247 87 120 207 98 114 419 21 19
Other
Cosopt / Trusopt 124 105 229 114 122 236 124 117 477 -14 -3
Bridion 58 60 118 41 47 89 52 60 201 27 33
Integrilin 53 60 113 64 56 120 53 57 230 7 -6
Diversified Brands
Cozaar / Hyzaar 336 337 674 426 406 832 404 427 1,663 -17 -19
Propecia 108 100 208 106 112 218 112 117 447 -11 -5
Zocor 103 96 199 127 107 234 110 111 456 -10 -15
Claritin Rx 87 48 134 120 65 186 55 74 314 -27 -28
Remeron 57 66 123 60 57 117 65 59 241 16 5
Proscar 51 55 106 60 53 113 58 52 223 4 -6
Vasotec / Vaseretic 53 49 102 57 59 116 57 58 231 -18 -12
Vaccines
Gardasil 284 324 608 214 277 490 445 274 1,209 17 24
ProQuad, M-M-R II and Varivax 255 316 571 244 291 535 391 276 1,202 9 7
RotaTeq 142 142 284 125 148 272 184 195 651 -4 4
Zostavax 76 148 224 24 122 146 108 78 332 22 54
Pneumovax 112 101 213 79 64 143 133 222 498 57 49
Other Pharmaceutical (2) 1,013 985 2,000 892 1,064 1,957 1,018 1,064 4,038 -7 2
ANIMAL HEALTH 821 865 1,686 758 802 1,560 826 868 3,253 8 8
CONSUMER CARE 554 552 1,106 517 541 1,058 421 361 1,840 2 5
Claritin OTC 169 145 314 167 134 301 118 92 511 8 4
Other Revenues (3) 274 333 608 486 448 935 421 310 1,666 -26 -35
Astra 186 223 409 322 306 628 299 256 1,184 -27 -35
------- ------- ------- ------- ------- ------- ------- ------- --------- -------- --------
* 100% or greater
Sum of quarterly amounts may not equal year-to-date amounts due to
rounding.
(1) Only select products are shown.
(2) Includes Pharmaceutical products not individually
shown above. Other Vaccines sales included in Other Pharmaceutical
were $60 million and $75 million for the first and second quarters
of 2012, respectively. Other Vaccines sales included in Other
Pharmaceutical were $54 million, $67 million, $100 million and $62
million for the first, second, third and fourth quarters of 2011,
respectively.
(3) Other revenues are primarily comprised of alliance
revenue, miscellaneous corporate revenues and third party
manufacturing sales.
SOURCE: Merck & Co., Inc.
Merck & Co., Inc.
Media Contacts:
Ron Rogers, 908-423-6449
Steve Cragle, 908-423-3461
or
Investor Contacts:
Carol Ferguson, 908-423-4465
Alex Kelly, 908-423-5185
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