Exhibit 99.1
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News Release |
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Media Contacts: |
Ron Rogers |
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Investor Contacts: |
Carol Ferguson |
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(908) 423-6449 |
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(908) 423-4465 |
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Steve Cragle |
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Justin Holko |
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(908) 423-3461 |
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(908) 423-5088 |
Merck Announces Third-Quarter 2012 Financial Results
· 2012 Third-Quarter Non-GAAP EPS Increased to $0.95, Excluding Certain Items; GAAP EPS of $0.56
· Worldwide Sales of $11.5 Billion, a Decrease of 4 Percent; Comparable to Third-Quarter 2011 Sales, Excluding the Unfavorable Impact of Foreign Exchange
· Double-Digit Global Sales Growth for JANUVIA, JANUMET, GARDASIL, VICTRELIS, ZOSTAVAX and ISENTRESS; Offset by the Decline in SINGULAIR Sales Following Patent Expiry in the United States
· Anticipates Multiple New Product Submissions in 2012-2013, Including Suvorexant and Odanacatib
· Narrows 2012 Full-Year Non-GAAP EPS Target to $3.78 to $3.82, Excluding Certain Items; GAAP EPS Range of $2.08 to $2.24
WHITEHOUSE STATION, N.J., Oct. 26, 2012 — Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the third quarter of 2012.
|
$ in millions, except EPS amounts |
|
Third |
|
Third |
|
|
Sales |
|
$11,488 |
|
$12,022 |
|
|
GAAP EPS |
|
0.56 |
|
0.55 |
|
|
Non-GAAP EPS that excludes items listed below1 |
|
0.95 |
|
0.94 |
|
|
GAAP Net Income2 |
|
1,729 |
|
1,692 |
|
|
Non-GAAP Net Income that excludes items listed below1,2 |
|
2,932 |
|
2,908 |
|
Non-GAAP (generally accepted accounting principles) earnings per share (EPS) for the third quarter of $0.95 exclude acquisition-related costs and restructuring costs.
1 Merck is providing certain 2012 and 2011 non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing this information enhances investors’ understanding of the company’s performance. This information should be considered in addition to, but not in lieu of, information prepared in accordance with GAAP. For a description of the items, see Table 2a including the related footnotes, attached to this release.
2 Net income attributable to Merck & Co., Inc.
A reconciliation of GAAP to non-GAAP net income and EPS is provided in the tables below. Year-to-date results can be found in the attached tables.
|
|
|
Third Quarter 2012 |
|
Third Quarter 2011 |
| ||||
|
$ in millions, except EPS amounts |
|
Net |
|
EPS |
|
Net |
|
EPS |
|
|
GAAP |
|
$1,729 |
|
$0.56 |
|
$1,692 |
|
$0.55 |
|
|
Difference |
|
1,203 |
|
0.39 |
3 |
1,216 |
|
0.39 |
3 |
|
Non-GAAP that excludes items listed below1 |
|
$2,932 |
|
$0.95 |
|
$2,908 |
|
$0.94 |
|
|
$ in millions |
|
Third |
|
Third |
|
|
|
|
|
|
Acquisition-related costs4 |
|
$1,340 |
|
$1,363 |
|
|
|
|
|
|
Restructuring costs |
|
163 |
|
277 |
|
|
|
|
|
|
Other5 |
|
— |
|
(137 |
) |
|
|
|
|
|
Net decrease (increase) in income before taxes |
|
1,503 |
|
1,503 |
|
|
|
|
|
|
Estimated income tax (benefit) expense |
|
(300 |
) |
(287 |
) |
|
|
|
|
|
Decrease (increase) in net income |
|
$1,203 |
|
$1,216 |
|
|
|
|
|
“Our strong global sales this quarter offset the impact of the SINGULAIR patent expiry in the U.S.,” said Kenneth C. Frazier, chairman and chief executive officer of Merck. “We will continue to drive value for our customers and shareholders through Merck’s four-part strategy of executing on our core business, expanding geographically in high-growth markets, extending our complementary businesses and excelling at managing our costs while investing for growth. With our robust pipeline, we remain on target to submit multiple new products for marketing approval between now and the end of 2013, including suvorexant for insomnia, odanacatib for osteoporosis and TREDAPTIVE for multiple lipid parameters.”
Select Revenue Highlights
Worldwide sales were $11.5 billion for the third quarter of 2012, a decrease of 4 percent. Excluding the unfavorable impact of foreign exchange, sales were comparable with the third quarter of 2011. Strong growth of key products offset the negative impact of the August 2012 loss of market exclusivity for SINGULAIR (montelukast sodium) in the United States.
The following table reflects sales of the company’s top pharmaceutical products, as well as total sales of animal health and consumer care products.
3 Represents the difference between calculated GAAP EPS and calculated non-GAAP EPS which may be different than the amount calculated by dividing the impact of the excluded items by the weighted-average shares.
4 Includes expenses for the amortization of intangible assets and amortization of purchase accounting adjustments to inventories recognized as a result of mergers and acquisitions, as well as intangible asset impairment charges. Also includes integration and other costs associated with mergers and acquisitions.
5 Amount for 2011 includes a gain on the divestiture of the company’s interest in the Johnson & Johnson°Merck Consumer Pharmaceuticals Company joint venture.
|
$ in millions |
|
Third Quarter |
|
Third Quarter |
|
Change |
|
|
Total Sales |
|
$11,488 |
|
$12,022 |
|
-4 |
% |
|
Pharmaceutical |
|
9,875 |
|
10,354 |
|
-5 |
% |
|
JANUVIA |
|
975 |
|
846 |
|
15 |
% |
|
ZETIA |
|
645 |
|
614 |
|
5 |
% |
|
SINGULAIR |
|
602 |
|
1,336 |
|
-55 |
% |
|
GARDASIL |
|
581 |
|
445 |
|
31 |
% |
|
REMICADE |
|
490 |
|
561 |
|
-13 |
% |
|
VYTORIN |
|
423 |
|
469 |
|
-10 |
% |
|
JANUMET |
|
405 |
|
350 |
|
16 |
% |
|
ISENTRESS |
|
399 |
|
343 |
|
16 |
% |
|
PROQUAD, M-M-R II and VARIVAX |
|
396 |
|
391 |
|
1 |
% |
|
COZAAR/HYZAAR |
|
295 |
|
404 |
|
-27 |
% |
|
Animal Health |
|
815 |
|
826 |
|
-1 |
% |
|
Consumer Care |
|
451 |
|
421 |
|
7 |
% |
|
Other Revenues |
|
347 |
|
421 |
|
-17 |
% |
Pharmaceutical Revenue Performance
Third-quarter pharmaceutical sales declined 5 percent to $9.9 billion, including a 5 percent negative impact due to foreign exchange. Strong sales growth for GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant], JANUVIA (sitagliptin), VICTRELIS (boceprevir), ZOSTAVAX (zoster vaccine live), ISENTRESS (raltegravir), and JANUMET (sitagliptin/metformin hydrochloride) offset the expected declines in sales of SINGULAIR, COZAAR (losartan potassium) and HYZAAR (losartan potassium and hydrochlorothiazide).
Sales from emerging markets accounted for approximately 20 percent of pharmaceutical sales in the third quarter. Sales growth in the emerging markets is being driven by primary care and women’s health, vaccines, hospital and specialty, and diversified brands. China continues to be a key driver with 19 percent growth for the third quarter, including a 1 percent benefit from foreign exchange.
Worldwide sales of the combined diabetes franchise of JANUVIA/JANUMET, medicines that help lower blood sugar levels in adults with type 2 diabetes, grew 15 percent to $1.4 billion in the third quarter of 2012 primarily driven by growth in the United States and Japan.
Sales of ZETIA (ezetimibe) and VYTORIN (ezetimibe/simvastatin), medicines for lowering LDL cholesterol, declined 1 percent to $1.1 billion in the third quarter driven by lower sales of VYTORIN, partially offset by growth of ZETIA in the United States.
Worldwide sales of SINGULAIR, a once-a-day oral medicine for the chronic treatment of asthma and the relief of symptoms of allergic rhinitis, declined $734 million, or 55 percent, to $602 million in the third quarter of 2012. The patent for SINGULAIR expired in the United States on Aug. 3, 2012 and will expire in major European markets in February 2013. The company is experiencing a significant and rapid reduction in sales in the United States and expects a similar decline in Europe following patent expiry there. SINGULAIR will retain marketing exclusivity in Japan until 2016.
Sales recorded by Merck for GARDASIL, a vaccine to help prevent certain diseases caused by four types of human papillomavirus (HPV), increased 31 percent to $581 million for the quarter driven by greater uptake in males in the United States and favorable performance in the emerging markets.
Combined sales of REMICADE (infliximab) and SIMPONI (golimumab), treatments for inflammatory diseases, declined 9 percent to $576 million for the third quarter of 2012. The combined sales grew 4 percent excluding foreign exchange.
ISENTRESS, an HIV integrase inhibitor for use in combination with other antiretroviral agents for the treatment of HIV-1 infection, grew 16 percent to $399 million in the third quarter driven by strong growth in the United States and the emerging markets.
Global sales of Merck’s antihypertensive medicines COZAAR and HYZAAR were down 27 percent to $295 million in the third quarter of 2012 due to the loss of market exclusivity in the United States and major European markets in 2010.
Sales of ZOSTAVAX, a vaccine for the prevention of herpes zoster, grew 87 percent to $202 million in the quarter. Growth this quarter was due to a positive response to supply availability and increased promotional efforts in the United States.
Sales of VICTRELIS, the company’s oral hepatitis C virus NS3/4A protease inhibitor, grew to $149 million in the quarter versus $31 million last year as the product continues to launch. VICTRELIS is approved in 64 countries and has launched in 31 of those markets.
Animal Health Revenue Performance
Animal Health sales totaled $815 million for the third quarter of 2012, a 1 percent decrease compared with the third quarter of 2011, which includes an 8 percent negative impact due to foreign exchange. Excluding the negative impact of foreign exchange, performance was driven by the cattle, poultry and companion animal segments. The Animal Health division launched the ACTIVYL line of products in the United States, which is an important addition to the companion animal product line.
Consumer Care Revenue Performance
Third-quarter global sales of Consumer Care were $451 million, an increase of 7 percent compared to the third quarter of 2011, including a 3 percent negative impact due to foreign exchange. The increase was primarily driven by the DR. SCHOLL’S footcare line and COPPERTONE suncare line.
Other Revenue Performance
Other revenues – primarily comprised of alliance revenue, miscellaneous corporate revenues and third-party manufacturing sales – declined 17 percent to $347 million. The
change was driven largely by lower revenue from AstraZeneca LP (AZLP) recorded by Merck, which declined 15 percent to $255 million, as well as by lower third-party manufacturing sales.
Third-Quarter Expense and Other Information
The costs detailed below totaled $9.2 billion on a GAAP basis during the third quarter of 2012 and include $1.5 billion of acquisition-related costs and restructuring costs.
|
|
|
Included in expenses for the period |
| ||||||
|
$ in millions |
|
GAAP |
|
Acquisition- |
|
Restructuring |
|
Non-GAAP1 |
|
|
Third Quarter 2012 |
|
|
|
|
|
|
|
|
|
|
Materials and production |
|
$4,137 |
|
$1,232 |
|
$60 |
|
$2,845 |
|
|
Marketing and administrative |
|
3,063 |
|
68 |
|
25 |
|
2,970 |
|
|
Research and development |
|
1,918 |
|
40 |
|
(32 |
) |
1,910 |
|
|
Restructuring costs |
|
110 |
|
— |
|
110 |
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
Third Quarter 2011 |
|
|
|
|
|
|
|
|
|
|
Materials and production |
|
$4,352 |
|
$1,284 |
|
$99 |
|
$2,969 |
|
|
Marketing and administrative |
|
3,340 |
|
57 |
|
31 |
|
3,252 |
|
|
Research and development |
|
1,954 |
|
22 |
|
28 |
|
1,904 |
|
|
Restructuring costs |
|
119 |
|
— |
|
119 |
|
— |
|
The gross margin was 64.0 percent for the third quarter of 2012 and 63.8 percent for the third quarter of 2011, reflecting 11.2 and 11.5 percentage point unfavorable impacts, respectively, from the acquisition-related costs and restructuring costs noted above.
Marketing and administrative expenses, on a non-GAAP basis, were $3.0 billion in the third quarter of 2012, a decrease from $3.3 billion in the third quarter of 2011. The decrease was primarily due to foreign exchange and productivity measures.
Research and development (R&D) expenses, on a non-GAAP basis, were $1.9 billion in the third quarter of 2012, which is in line with the third quarter of 2011.
Equity income from affiliates was $158 million for the third quarter of 2012, which primarily reflects the performance of AZLP and Sanofi Pasteur MSD.
Other (income) expense, net was $200 million of expense in the third quarter of 2012, compared to $66 million of expense in the third quarter of 2011. The third quarter of 2011 reflects a $136 million gain on the divestiture of the company’s interest in the Johnson & Johnson°Merck Consumer Pharmaceuticals Company joint venture.
The GAAP effective tax rate of 20.5 percent for the third quarter of 2012 reflects the impact of acquisition-related costs and restructuring costs. The non-GAAP effective tax rate, which excludes these items, was 20.3 percent for the quarter. Both the GAAP and non-GAAP effective tax rates reflect the favorable impacts of a settlement with a foreign tax authority and the realization of foreign tax credits.
Key Developments
The company noted the following developments:
· In October, entered into an exclusive worldwide licensing agreement for AiCuris’ late-stage antiviral candidate for the treatment and prevention of human cytomegalovirus infection in transplant recipients;
· Completed a study of sugammadex, a neuromuscular blocker reversal agent, to assess bleeding risk when co-administered with anticoagulants in a surgical setting. The company remains on track to resubmit sugammadex to the FDA this year;
· Announced results from a Phase II trial for odanacatib, an investigational cathepsin K inhibitor in development for the treatment of osteoporosis in post-menopausal women. In that Phase II trial, odanacatib significantly increased bone mineral density over a two-year period in patients previously treated with alendronate;
· Presented Phase IIb data for MK-3102, the company’s investigational once-weekly DPP-4 inhibitor in development for the treatment of type 2 diabetes. MK-3102 significantly lowered blood sugar in this 12-week study compared with placebo, with an incidence of symptomatic hypoglycemia that was similar to placebo, in patients with type 2 diabetes. The company has initiated the Phase III clinical program;
· Presented new clinical data for suvorexant that showed patients who had been taking suvorexant for 12 months and were then switched to placebo for two months saw their insomnia return, but clinically meaningful withdrawal symptoms and rebound insomnia did not emerge;
· Announced plans to file applications for vorapaxar, an investigational anti-thrombotic medicine, in the United States and Europe in 2013. The company will seek an indication for the prevention of cardiovascular events in patients with a history of heart attack and no history of transient ischemic attack or stroke.
Financial Targets
Merck narrows the range of full-year 2012 non-GAAP EPS to be between $3.78 and $3.82 and the 2012 GAAP EPS range to be $2.08 to $2.24. The 2012 non-GAAP range excludes acquisition-related costs and costs related to restructuring programs.
Merck continues to expect full-year 2012 revenues to be at or near 2011 levels on a constant currency basis. At current exchange rates, sales would be affected unfavorably by approximately 1 percent for the fourth quarter and more than 2 percent for the full year.
In addition, the company expects full-year 2012 non-GAAP R&D expenses to be higher than the 2011 level. The company continues to expect the full-year 2012 non-GAAP tax rate to be approximately 25 percent.
A reconciliation of anticipated 2012 EPS as reported in accordance with GAAP to non-GAAP EPS that excludes certain items is provided in the table below.
|
$ in millions, except EPS amounts |
|
Full-Year 2012 |
|
|
GAAP EPS |
|
$2.08 to $2.24 |
|
|
Difference3 |
|
1.70 to 1.58 |
|
|
Non-GAAP EPS that excludes items listed below |
|
$3.78 to $3.82 |
|
|
|
|
|
|
|
Acquisition-related costs4 |
|
$5,300 to $5,100 |
|
|
Restructuring costs |
|
1,100 to 800 |
|
|
Net decrease (increase) in income before taxes |
|
6,400 to 5,900 |
|
|
Estimated income tax (benefit) expense |
|
(1,160) to (1,050) |
|
|
Decrease (increase) in net income |
|
$5,240 to $4,850 |
|
Total Employees
As of Sept. 30, 2012, Merck had approximately 84,000 employees worldwide.
Earnings Conference Call
Investors are invited to a live audio webcast of Merck’s third-quarter earnings conference call today at 8 a.m. EDT by visiting Merck’s Internet site, www.merck.com/investors/events-and-presentations/home.html. Institutional investors and analysts can participate in the call by dialing (706) 758-9927 or (877) 381-5782. Journalists are invited to monitor the call by dialing (706) 758-9928 or (800) 399-7917. A replay of the call will be available starting at 11 a.m. EDT today for approximately one week. To listen to the replay, dial (404) 537-3406 or (855) 859-2056 and enter ID No. 30586503.
About Merck
Today’s Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.
Forward-Looking Statement
This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger
between Merck and Schering-Plough, including future financial and operating results, the combined company’s plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that all of the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; Merck’s ability to accurately predict future market conditions; dependence on the effectiveness of Merck’s patents and other protections for innovative products; and the exposure to litigation and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2011 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
###
MERCK & CO., INC.
CONSOLIDATED STATEMENT OF OPERATIONS - GAAP
(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)
(UNAUDITED)
Table 1
|
|
|
GAAP |
|
|
|
GAAP |
|
|
| ||||||||||
|
|
|
|
|
|
|
|
|
Sep YTD |
|
Sep YTD |
|
|
| ||||||
|
|
|
3Q12 |
|
3Q11 |
|
% Change |
|
2012 |
|
2011 |
|
% Change |
| ||||||
|
Sales |
|
$11,488 |
|
|
$12,022 |
|
|
-4 |
% |
|
$35,530 |
|
|
$35,753 |
|
|
-1 |
% |
|
|
Costs, Expenses and Other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Materials and production (1) |
|
4,137 |
|
|
4,352 |
|
|
-5 |
% |
|
12,286 |
|
|
12,695 |
|
|
-3 |
% |
|
|
Marketing and administrative (1) |
|
3,063 |
|
|
3,340 |
|
|
-8 |
% |
|
9,386 |
|
|
10,029 |
|
|
-6 |
% |
|
|
Research and development (1) |
|
1,918 |
|
|
1,954 |
|
|
-2 |
% |
|
5,944 |
|
|
6,048 |
|
|
-2 |
% |
|
|
Restructuring costs (2) |
|
110 |
|
|
119 |
|
|
-8 |
% |
|
473 |
|
|
773 |
|
|
-39 |
% |
|
|
Equity income from affiliates (3) |
|
(158 |
) |
|
(161 |
) |
|
-2 |
% |
|
(410 |
) |
|
(354 |
) |
|
16 |
% |
|
|
Other (income) expense, net (1)(4) |
|
200 |
|
|
66 |
|
|
* |
|
|
446 |
|
|
809 |
|
|
-45 |
% |
|
|
Income Before Taxes |
|
2,218 |
|
|
2,352 |
|
|
-6 |
% |
|
7,405 |
|
|
5,753 |
|
|
29 |
% |
|
|
Income Tax Provision |
|
455 |
|
|
628 |
|
|
|
|
|
2,055 |
|
|
904 |
|
|
|
|
|
|
Net Income |
|
1,763 |
|
|
1,724 |
|
|
2 |
% |
|
5,350 |
|
|
4,849 |
|
|
10 |
% |
|
|
Less: Net Income Attributable to Noncontrolling Interests |
|
34 |
|
|
32 |
|
|
|
|
|
89 |
|
|
89 |
|
|
|
|
|
|
Net Income Attributable to Merck & Co., Inc. |
|
$ 1,729 |
|
|
$ 1,692 |
|
|
2 |
% |
|
$ 5,261 |
|
|
$ 4,760 |
|
|
11 |
% |
|
|
Earnings per Common Share Assuming Dilution (5) |
|
$ 0.56 |
|
|
$ 0.55 |
|
|
2 |
% |
|
$ 1.71 |
|
|
$ 1.53 |
|
|
12 |
% |
|
|
Average Shares Outstanding Assuming Dilution |
|
3,079 |
|
|
3,091 |
|
|
|
|
|
3,077 |
|
|
3,102 |
|
|
|
|
|
|
Tax Rate (6) |
|
20.5 |
% |
|
26.7 |
% |
|
|
|
|
27.8 |
% |
|
15.7 |
% |
|
|
|
|
*100% or greater
(1) Amounts include the impact of acquisition-related costs and restructuring costs. See accompanying tables for details.
(2) Represents separation and other related costs associated with restructuring activities under the company’s formal restructuring programs.
(3) Primarily reflects equity income from the AstraZeneca LP and Sanofi Pasteur MSD partnerships.
(4) Other (income) expense, net in the third quarter and first nine months of 2011 includes a $136 million gain on the divestiture of the company’s interest in the Johnson & JohnsonºMerck Consumer Pharmaceuticals Company joint venture. In addition, other (income) expense, net in the first nine months of 2011 includes a charge of $500 million related to the resolution of the arbitration proceeding with Johnson & Johnson and a $127 million gain on the sale of certain manufacturing facilities and related assets.
(5) The company calculates earnings per share pursuant to the two-class method which requires the allocation of net income between common shareholders and participating security holders. Net income attributable to Merck & Co., Inc. common shareholders used to calculate earnings per common share assuming dilution was $1,729 million and $1,689 million for the third quarter of 2012 and 2011, respectively, and was $5,257 million and $4,748 million for the first nine months of 2012 and 2011, respectively.
(6) The GAAP effective tax rates for the third quarter and first nine months of 2012 were 20.5% and 27.8%, respectively. Excluding the impact of the non-GAAP reconciling items detailed in the accompanying tables, the effective tax rates were 20.3% and 23.8% for the third quarter and first nine months of 2012, respectively. Both the GAAP and non-GAAP effective tax rates for the third quarter and first nine months of 2012 reflect the favorable impacts of a settlement with a foreign tax authority and the realization of foreign tax credits. The GAAP effective tax rates for the third quarter and first nine months of 2011 were 26.7% and 15.7%, respectively. Excluding the impact of the non-GAAP reconciling items detailed in the accompanying tables, the effective tax rates were 23.7% and 24.5% for the third quarter and first nine months of 2011, respectively.
MERCK & CO., INC.
CONSOLIDATED STATEMENT OF OPERATIONS
GAAP TO NON-GAAP RECONCILIATION
THIRD QUARTER 2012
(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)
(UNAUDITED)
Table 2a
|
|
|
GAAP |
|
Acquisition- |
|
Restructuring |
|
Adjustment |
|
Non-GAAP |
| |||
|
Sales |
|
$ |
11,488 |
|
|
|
|
|
$ |
— |
|
$ |
11,488 |
|
|
Costs, Expenses and Other |
|
|
|
|
|
|
|
|
|
|
| |||
|
Materials and production |
|
4,137 |
|
1,232 |
|
60 |
|
1,292 |
|
2,845 |
| |||
|
Marketing and administrative |
|
3,063 |
|
68 |
|
25 |
|
93 |
|
2,970 |
| |||
|
Research and development |
|
1,918 |
|
40 |
|
(32 |
) |
8 |
|
1,910 |
| |||
|
Restructuring costs |
|
110 |
|
|
|
110 |
|
110 |
|
— |
| |||
|
Equity income from affiliates |
|
(158 |
) |
|
|
|
|
— |
|
(158 |
) | |||
|
Other (income) expense, net |
|
200 |
|
|
|
|
|
— |
|
200 |
| |||
|
Income Before Taxes |
|
2,218 |
|
(1,340 |
) |
(163 |
) |
(1,503 |
) |
3,721 |
| |||
|
Taxes on Income |
|
455 |
|
|
|
|
|
(300 |
)(3) |
755 |
| |||
|
Net Income |
|
1,763 |
|
|
|
|
|
(1,203 |
) |
2,966 |
| |||
|
Less: Net Income Attributable to Noncontrolling Interests |
|
34 |
|
|
|
|
|
— |
|
34 |
| |||
|
Net Income Attributable to Merck & Co., Inc. |
|
$ |
1,729 |
|
|
|
|
|
$ |
(1,203 |
) |
$ |
2,932 |
|
|
Earnings per Common Share Assuming Dilution |
|
$ |
0.56 |
|
|
|
|
|
|
|
$ |
0.95 |
(4) | |
|
Average Shares Outstanding Assuming Dilution |
|
3,079 |
|
|
|
|
|
|
|
3,079 |
| |||
|
Tax Rate |
|
20.5 |
% |
|
|
|
|
|
|
20.3 |
% | |||
Merck is providing non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing this information enhances investors’ understanding of the company’s performance. This information should be considered in addition to, but not in lieu of, information prepared in accordance with GAAP.
(1) Amounts included in materials and production costs reflect expenses for the amortization of intangible assets recognized as a result of mergers and acquisitions. Amounts included in marketing and administrative expenses reflect merger integration costs. Amounts included in research and development expenses represent in-process research and development (“IPR&D”) impairment charges.
(2) Amounts primarily include employee separation costs and accelerated depreciation associated with facilities to be closed or divested related to actions under the company’s formal restructuring programs. In the third quarter of 2012, the company recorded an adjustment to accelerated depreciation costs included in research and development expenses revising previously recorded amounts for certain facilities.
(3) Represents the estimated tax impact on the reconciling items.
(4) The company calculates earnings per share pursuant to the two-class method which requires the allocation of net income between common shareholders and participating security holders. Net income attributable to Merck & Co., Inc. common shareholders used to calculate non-GAAP earnings per common share assuming dilution was $2,932 million for the third quarter of 2012.
MERCK & CO., INC.
CONSOLIDATED STATEMENT OF OPERATIONS
GAAP TO NON-GAAP RECONCILIATION
NINE MONTHS ENDED SEPTEMBER 30, 2012
(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)
(UNAUDITED)
Table 2b
|
|
|
GAAP |
|
Acquisition- |
|
Restructuring |
|
Adjustment |
|
Non-GAAP |
| |||
|
Sales |
|
$ |
35,530 |
|
|
|
|
|
$ |
— |
|
$ |
35,530 |
|
|
Costs, Expenses and Other |
|
|
|
|
|
|
|
|
|
|
| |||
|
Materials and production |
|
12,286 |
|
3,687 |
|
148 |
|
3,835 |
|
8,451 |
| |||
|
Marketing and administrative |
|
9,386 |
|
183 |
|
70 |
|
253 |
|
9,133 |
| |||
|
Research and development |
|
5,944 |
|
176 |
|
54 |
|
230 |
|
5,714 |
| |||
|
Restructuring costs |
|
473 |
|
|
|
473 |
|
473 |
|
— |
| |||
|
Equity income from affiliates |
|
(410 |
) |
|
|
|
|
— |
|
(410 |
) | |||
|
Other (income) expense, net |
|
446 |
|
|
|
|
|
— |
|
446 |
| |||
|
Income Before Taxes |
|
7,405 |
|
(4,046 |
) |
(745 |
) |
(4,791 |
) |
12,196 |
| |||
|
Taxes on Income |
|
2,055 |
|
|
|
|
|
(848 |
)(3) |
2,903 |
| |||
|
Net Income |
|
5,350 |
|
|
|
|
|
(3,943 |
) |
9,293 |
| |||
|
Less: Net Income Attributable to Noncontrolling Interests |
|
89 |
|
|
|
|
|
— |
|
89 |
| |||
|
Net Income Attributable to Merck & Co., Inc. |
|
$ |
5,261 |
|
|
|
|
|
$ |
(3,943 |
) |
$ |
9,204 |
|
|
Earnings per Common Share Assuming Dilution |
|
$ |
1.71 |
|
|
|
|
|
|
|
$ |
2.99 |
(4) | |
|
Average Shares Outstanding Assuming Dilution |
|
3,077 |
|
|
|
|
|
|
|
3,077 |
| |||
|
Tax Rate |
|
27.8 |
% |
|
|
|
|
|
|
23.8 |
% | |||
Merck is providing non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing this information enhances investors’ understanding of the company’s performance. This information should be considered in addition to, but not in lieu of, information prepared in accordance with GAAP.
(1) Amounts included in materials and production costs reflect expenses for the amortization of intangible assets recognized as a result of mergers and acquisitions. Amounts included in marketing and administrative expenses reflect merger integration costs. Amounts included in research and development expenses represent in-process research and development (“IPR&D”) impairment charges.
(2) Amounts primarily include employee separation costs and accelerated depreciation associated with facilities to be closed or divested related to actions under the company’s formal restructuring programs.
(3) Represents the estimated tax impact on the reconciling items.
(4) The company calculates earnings per share pursuant to the two-class method which requires the allocation of net income between common shareholders and participating security holders. Net income attributable to Merck & Co., Inc. common shareholders used to calculate non-GAAP earnings per common share assuming dilution was $9,198 million for the first nine months of 2012.
MERCK & CO., INC.
FRANCHISE / KEY PRODUCT SALES
(AMOUNTS IN MILLIONS)
Table 3
|
|
|
2012 |
|
2011 |
|
% Change |
|
% Change |
| ||||||||||||||||||||||||||
|
|
|
1Q |
|
2Q |
|
3Q |
|
Sep YTD |
|
1Q |
|
2Q |
|
3Q |
|
Sep YTD |
|
4Q |
|
Full Year |
|
3Q |
|
Sep YTD |
| ||||||||||
|
TOTAL SALES (1) |
|
$ |
11,731 |
|
$ |
12,311 |
|
$ |
11,488 |
|
$ |
35,530 |
|
$ |
11,580 |
|
$ |
12,151 |
|
$ |
12,022 |
|
$ |
35,753 |
|
$ |
12,294 |
|
$ |
48,047 |
|
-4 |
|
-1 |
|
|
PHARMACEUTICAL |
|
10,082 |
|
10,560 |
|
9,875 |
|
30,517 |
|
9,820 |
|
10,360 |
|
10,354 |
|
30,534 |
|
10,755 |
|
41,289 |
|
-5 |
|
— |
| ||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||||
|
Primary Care and Women’s Health |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||||
|
Cardiovascular |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||||
|
Zetia |
|
614 |
|
632 |
|
645 |
|
1,891 |
|
582 |
|
592 |
|
614 |
|
1,788 |
|
640 |
|
2,428 |
|
5 |
|
6 |
| ||||||||||
|
Vytorin |
|
444 |
|
445 |
|
423 |
|
1,312 |
|
480 |
|
459 |
|
469 |
|
1,407 |
|
475 |
|
1,882 |
|
-10 |
|
-7 |
| ||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||||
|
Diabetes & Obesity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||||
|
Januvia |
|
919 |
|
1,058 |
|
975 |
|
2,952 |
|
739 |
|
779 |
|
846 |
|
2,364 |
|
960 |
|
3,324 |
|
15 |
|
25 |
| ||||||||||
|
Janumet |
|
392 |
|
411 |
|
405 |
|
1,207 |
|
305 |
|
321 |
|
350 |
|
977 |
|
386 |
|
1,363 |
|
16 |
|
24 |
| ||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||||
|
Respiratory |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||||
|
Singulair |
|
1,340 |
|
1,431 |
|
602 |
|
3,373 |
|
1,328 |
|
1,354 |
|
1,336 |
|
4,018 |
|
1,461 |
|
5,479 |
|
-55 |
|
-16 |
| ||||||||||
|
Nasonex |
|
375 |
|
293 |
|
292 |
|
960 |
|
373 |
|
323 |
|
266 |
|
962 |
|
325 |
|
1,286 |
|
10 |
|
— |
| ||||||||||
|
Clarinex |
|
134 |
|
140 |
|
64 |
|
337 |
|
155 |
|
209 |
|
128 |
|
492 |
|
129 |
|
621 |
|
-50 |
|
-32 |
| ||||||||||
|
Asmanex |
|
48 |
|
51 |
|
42 |
|
141 |
|
60 |
|
47 |
|
42 |
|
149 |
|
57 |
|
206 |
|
— |
|
-6 |
| ||||||||||
|
Dulera |
|
39 |
|
50 |
|
52 |
|
140 |
|
13 |
|
25 |
|
22 |
|
59 |
|
37 |
|
96 |
|
* |
|
* |
| ||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||||
|
Women’s Health & Endocrine |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||||
|
Fosamax |
|
184 |
|
186 |
|
152 |
|
522 |
|
208 |
|
221 |
|
215 |
|
644 |
|
211 |
|
855 |
|
-29 |
|
-19 |
| ||||||||||
|
NuvaRing |
|
146 |
|
157 |
|
156 |
|
459 |
|
142 |
|
154 |
|
159 |
|
455 |
|
168 |
|
623 |
|
-2 |
|
1 |
| ||||||||||
|
Follistim AQ |
|
116 |
|
125 |
|
111 |
|
352 |
|
133 |
|
143 |
|
129 |
|
404 |
|
126 |
|
530 |
|
-14 |
|
-13 |
| ||||||||||
|
Implanon |
|
76 |
|
85 |
|
93 |
|
254 |
|
60 |
|
81 |
|
80 |
|
220 |
|
74 |
|
294 |
|
16 |
|
15 |
| ||||||||||
|
Cerazette |
|
67 |
|
72 |
|
64 |
|
202 |
|
59 |
|
66 |
|
74 |
|
199 |
|
69 |
|
268 |
|
-14 |
|
2 |
| ||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||||
|
Other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||||
|
Maxalt |
|
156 |
|
154 |
|
166 |
|
476 |
|
173 |
|
131 |
|
156 |
|
460 |
|
178 |
|
639 |
|
7 |
|
3 |
| ||||||||||
|
Arcoxia |
|
112 |
|
117 |
|
109 |
|
338 |
|
114 |
|
100 |
|
108 |
|
321 |
|
110 |
|
431 |
|
2 |
|
5 |
| ||||||||||
|
Avelox |
|
73 |
|
44 |
|
30 |
|
146 |
|
106 |
|
61 |
|
59 |
|
227 |
|
95 |
|
322 |
|
-50 |
|
-35 |
| ||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||||
|
Hospital and Specialty |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||||
|
Immunology |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||||
|
Remicade |
|
519 |
|
518 |
|
490 |
|
1,527 |
|
753 |
|
842 |
|
561 |
|
2,156 |
|
511 |
|
2,667 |
|
-13 |
|
-29 |
| ||||||||||
|
Simponi |
|
74 |
|
76 |
|
86 |
|
236 |
|
54 |
|
75 |
|
74 |
|
203 |
|
61 |
|
264 |
|
15 |
|
16 |
| ||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||||
|
Infectious Disease |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||||
|
Isentress |
|
337 |
|
398 |
|
399 |
|
1,133 |
|
292 |
|
337 |
|
343 |
|
972 |
|
387 |
|
1,359 |
|
16 |
|
17 |
| ||||||||||
|
PegIntron |
|
162 |
|
183 |
|
165 |
|
510 |
|
166 |
|
154 |
|
163 |
|
482 |
|
175 |
|
657 |
|
1 |
|
6 |
| ||||||||||
|
Cancidas |
|
145 |
|
166 |
|
163 |
|
474 |
|
158 |
|
168 |
|
150 |
|
476 |
|
164 |
|
640 |
|
8 |
|
— |
| ||||||||||
|
Victrelis |
|
111 |
|
126 |
|
149 |
|
387 |
|
1 |
|
21 |
|
31 |
|
53 |
|
87 |
|
140 |
|
* |
|
* |
| ||||||||||
|
Invanz |
|
101 |
|
110 |
|
118 |
|
329 |
|
87 |
|
103 |
|
107 |
|
296 |
|
110 |
|
406 |
|
10 |
|
11 |
| ||||||||||
|
Primaxin |
|
88 |
|
104 |
|
109 |
|
301 |
|
136 |
|
136 |
|
124 |
|
397 |
|
119 |
|
515 |
|
-12 |
|
-24 |
| ||||||||||
|
Noxafil |
|
59 |
|
66 |
|
66 |
|
191 |
|
55 |
|
56 |
|
61 |
|
171 |
|
59 |
|
230 |
|
9 |
|
12 |
| ||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||||
|
Oncology |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||||
|
Temodar |
|
237 |
|
225 |
|
227 |
|
688 |
|
248 |
|
234 |
|
223 |
|
704 |
|
230 |
|
935 |
|
2 |
|
-2 |
| ||||||||||
|
Emend |
|
102 |
|
145 |
|
111 |
|
358 |
|
87 |
|
120 |
|
98 |
|
305 |
|
114 |
|
419 |
|
12 |
|
17 |
| ||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||||
|
Other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||||
|
Cosopt / Trusopt |
|
124 |
|
105 |
|
102 |
|
331 |
|
114 |
|
122 |
|
124 |
|
360 |
|
117 |
|
477 |
|
-18 |
|
-8 |
| ||||||||||
|
Bridion |
|
58 |
|
60 |
|
68 |
|
186 |
|
41 |
|
47 |
|
52 |
|
141 |
|
60 |
|
201 |
|
29 |
|
32 |
| ||||||||||
|
Integrilin |
|
53 |
|
60 |
|
48 |
|
160 |
|
64 |
|
56 |
|
53 |
|
172 |
|
57 |
|
230 |
|
-9 |
|
-7 |
| ||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||||
|
Diversified Brands |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||||
|
Cozaar / Hyzaar |
|
336 |
|
337 |
|
295 |
|
969 |
|
426 |
|
406 |
|
404 |
|
1,236 |
|
427 |
|
1,663 |
|
-27 |
|
-22 |
| ||||||||||
|
Propecia |
|
108 |
|
100 |
|
104 |
|
312 |
|
106 |
|
112 |
|
112 |
|
330 |
|
117 |
|
447 |
|
-7 |
|
-5 |
| ||||||||||
|
Zocor |
|
103 |
|
96 |
|
86 |
|
285 |
|
127 |
|
107 |
|
110 |
|
345 |
|
111 |
|
456 |
|
-22 |
|
-17 |
| ||||||||||
|
Claritin Rx |
|
87 |
|
48 |
|
47 |
|
181 |
|
120 |
|
65 |
|
55 |
|
240 |
|
74 |
|
314 |
|
-14 |
|
-25 |
| ||||||||||
|
Remeron |
|
57 |
|
66 |
|
52 |
|
175 |
|
60 |
|
57 |
|
65 |
|
181 |
|
59 |
|
241 |
|
-19 |
|
-3 |
| ||||||||||
|
Proscar |
|
51 |
|
55 |
|
55 |
|
160 |
|
60 |
|
53 |
|
58 |
|
171 |
|
52 |
|
223 |
|
-6 |
|
-6 |
| ||||||||||
|
Vasotec / Vaseretic |
|
53 |
|
49 |
|
42 |
|
144 |
|
57 |
|
59 |
|
57 |
|
173 |
|
58 |
|
231 |
|
-27 |
|
-17 |
| ||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||||
|
Vaccines |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||||
|
Gardasil |
|
284 |
|
324 |
|
581 |
|
1,189 |
|
214 |
|
277 |
|
445 |
|
935 |
|
274 |
|
1,209 |
|
31 |
|
27 |
| ||||||||||
|
ProQuad, M-M-R II and Varivax |
|
255 |
|
316 |
|
396 |
|
967 |
|
244 |
|
291 |
|
391 |
|
927 |
|
276 |
|
1,202 |
|
1 |
|
4 |
| ||||||||||
|
RotaTeq |
|
142 |
|
142 |
|
150 |
|
433 |
|
125 |
|
148 |
|
184 |
|
457 |
|
195 |
|
651 |
|
-19 |
|
-5 |
| ||||||||||
|
Zostavax |
|
76 |
|
148 |
|
202 |
|
426 |
|
24 |
|
122 |
|
108 |
|
254 |
|
78 |
|
332 |
|
87 |
|
68 |
| ||||||||||
|
Pneumovax |
|
112 |
|
101 |
|
160 |
|
372 |
|
79 |
|
64 |
|
133 |
|
276 |
|
222 |
|
498 |
|
20 |
|
35 |
| ||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||||
|
Other Pharmaceutical (2) |
|
1,013 |
|
985 |
|
1,023 |
|
3,031 |
|
892 |
|
1,064 |
|
1,015 |
|
2,975 |
|
1,064 |
|
4,038 |
|
1 |
|
2 |
| ||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||||
|
ANIMAL HEALTH |
|
821 |
|
865 |
|
815 |
|
2,501 |
|
758 |
|
802 |
|
826 |
|
2,385 |
|
868 |
|
3,253 |
|
-1 |
|
5 |
| ||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||||
|
CONSUMER CARE |
|
554 |
|
552 |
|
451 |
|
1,557 |
|
517 |
|
541 |
|
421 |
|
1,479 |
|
361 |
|
1,840 |
|
7 |
|
5 |
| ||||||||||
|
Claritin OTC |
|
169 |
|
145 |
|
118 |
|
432 |
|
167 |
|
134 |
|
118 |
|
419 |
|
92 |
|
511 |
|
— |
|
3 |
| ||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||||
|
Other Revenues (3) |
|
274 |
|
333 |
|
347 |
|
955 |
|
486 |
|
448 |
|
421 |
|
1,355 |
|
310 |
|
1,666 |
|
-17 |
|
-30 |
| ||||||||||
|
Astra |
|
186 |
|
223 |
|
255 |
|
664 |
|
322 |
|
306 |
|
299 |
|
928 |
|
256 |
|
1,184 |
|
-15 |
|
-28 |
| ||||||||||
* 100% or greater
Sum of quarterly amounts may not equal year-to-date amounts due to rounding.
(1) Only select products are shown.
(2) Includes Pharmaceutical products not individually shown above. Other Vaccines sales included in Other Pharmaceutical were $60 million, $75 million, and $116 million for the first, second, and third quarters of 2012, respectively. Other Vaccines sales included in Other Pharmaceutical were $54 million, $67 million, $100 million and $62 million for the first, second, third and fourth quarters of 2011, respectively.
(3) Other revenues are primarily comprised of alliance revenue, miscellaneous corporate revenues and third party manufacturing sales.