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EX-99.2 - EX-99.2 - Merck & Co., Inc.a15-3619_1ex99d2.htm

Exhibit 99.1

 

GRAPHIC

 

News Release

 

FOR IMMEDIATE RELEASE

 

Media Contacts:

Lainie Keller

Investor Contacts:

Justin Holko

 

(908) 236-5036

 

(908) 740-1879

 

 

 

 

 

Steven Cragle

 

Joe Romanelli

 

(908) 740-1801

 

(908) 740-1986

 

Merck Announces Fourth-Quarter and Full-Year 2014 Financial Results

 

·                  Fourth-Quarter 2014 Non-GAAP EPS of $0.87, Excluding Certain Items; GAAP EPS of $2.54; Full-Year 2014 Non-GAAP EPS of $3.49, Excluding Certain Items; GAAP EPS of $4.07

 

·                  2015 Full-Year Non-GAAP EPS Target of $3.32 to $3.47, Including a $0.27 Negative Impact From Foreign Exchange and Excluding Certain Items; GAAP EPS Range of $1.62 to $1.91

 

·                  Fourth-Quarter 2014 Worldwide Sales of $10.5 Billion, a Decrease of 7 Percent, Reflecting Unfavorable Impact of Patent Expiries and Divestitures and a 3 Percent Negative Impact From Foreign Exchange

 

·                  Full-Year 2014 Worldwide Sales of $42.2 Billion, a Decrease of 4 Percent, Reflecting Unfavorable Impact of Patent Expiries and Divestitures and a 1 Percent Negative Impact From Foreign Exchange

 

·                  Full-Year Results Reflect Sales Growth in Immunology, Diabetes, Hospital Acute Care, Vaccines and Animal Health and Sales Declines in Hepatitis C

 

·                  Six New Products Were Approved in the United States in 2014; Company Accelerated KEYTRUDA and Hepatitis C Clinical Development Programs

 

KENILWORTH, N.J., Feb. 4, 2015 — Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the fourth quarter and full year of 2014.

 

 

 

Fourth Quarter

 

Year Ended

 

$ in millions, except EPS amounts

 

2014

 

2013

 

Dec. 31,
2014

 

Dec. 31,
2013

 

Sales

 

$

10,482

 

$

11,319

 

$

42,237

 

$

44,033

 

GAAP EPS

 

2.54

 

0.26

 

4.07

 

1.47

 

Non-GAAP EPS that excludes items listed below(1)

 

0.87

 

0.88

 

3.49

 

3.49

 

GAAP Net Income(2)

 

7,316

 

781

 

11,920

 

4,404

 

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

 

2,504

 

2,599

 

10,215

 

10,443

 

 

(1) Merck is providing certain 2014 and 2013 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 Tables 2a and 2b, including the related footnotes, attached to this release.

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

 



 

Non-GAAP (generally accepted accounting principles) earnings per share (EPS) of $0.87 for the fourth quarter and $3.49 for the full year of 2014 exclude acquisition- and divestiture-related costs, restructuring costs and certain other items, as well as an $11.2 billion gain on the divestiture of the Consumer Care business.

 

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

 

 

 

Fourth Quarter

 

Year Ended

 

$ in millions, except EPS amounts

 

2014

 

2013

 

Dec. 31,
2014

 

Dec. 31,
2013

 

EPS

 

 

 

 

 

 

 

 

 

GAAP EPS

 

$

2.54

 

$

0.26

 

$

4.07

 

$

1.47

 

Difference(3)

 

(1.67

)

0.62

 

(0.58

)

2.02

 

Non-GAAP EPS that excludes items listed below(1)

 

$

0.87

 

$

0.88

 

$

3.49

 

$

3.49

 

 

 

 

 

 

 

 

 

 

 

Net Income

 

 

 

 

 

 

 

 

 

GAAP net income(2)

 

$

7,316

 

$

781

 

$

11,920

 

$

4,404

 

Difference

 

(4,812

)

1,818

 

(1,705

)

6,039

 

Non-GAAP net income that excludes items listed below(1),(2)

 

$

2,504

 

$

2,599

 

$

10,215

 

$

10,443

 

 

 

 

 

 

 

 

 

 

 

Decrease (Increase) in Net Income Due to Excluded Items:

 

 

 

 

 

 

 

 

 

Acquisition- and divestiture-related costs(4)

 

$

1,394

 

$

1,348

 

$

5,946

 

$

5,549

 

Restructuring costs

 

619

 

962

 

1,978

 

2,401

 

Gain on sale of Merck Consumer Care

 

(11,209

)

 

(11,209

)

 

Gain on AstraZeneca option exercise

 

 

 

(741

)

 

Gain on divestiture of certain ophthalmic products

 

(84

)

 

(480

)

 

Loss on extinguishment of debt

 

628

 

 

628

 

 

Additional year of health care reform fee

 

 

 

193

 

 

Other

 

(14

)

 

(9

)

(13

)

Net decrease (increase) in income before taxes

 

(8,666

)

2,310

 

(3,694

)

7,937

 

Income tax (benefit) expense(5)

 

3,854

 

(492

)

2,045

 

(1,898

)

Acquisition- and divestiture-related costs attributable to non-controlling interests

 

 

 

(56

)

 

Decrease (increase) in net income

 

$

(4,812

)

$

1,818

 

$

(1,705

)

$

6,039

 

 

Select Business Highlights

 

In 2014, Merck took proactive, strategic action to sharpen its commercial and research and development (R&D) focus, redesign its operating model and reduce its cost base. Through consistent execution of these actions, the company continued to transform into a more competitive, more innovative company and is building a platform for sustained future growth.

 

(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, intangible asset impairment charges and expense or income related to changes in the fair value measurement of contingent consideration. Also includes merger integration costs, as well as transaction and certain other costs related to business acquisitions and divestitures.

(5) Includes the estimated tax impact on the reconciling items. In addition, amount for full-year 2014 includes a net benefit of $517 million recorded in connection with AstraZeneca’s option exercise, as well as a benefit of approximately $300 million associated with a capital loss generated in the first quarter. Amount for full-year 2013 also includes net benefits of approximately $325 million related to the settlements of certain federal income tax issues.

 

Page 2



 

“Our stronger focus has led to better, consistent execution, and our results in 2014 demonstrate the significant progress we’ve made in evolving the company to better serve health care markets around the world,” said Kenneth C. Frazier, chairman and chief executive officer, Merck. “As we look forward to 2015 and beyond, we will continue to focus our resources on those internal and external opportunities that can generate the most value for patients, customers and shareholders.”

 

“While we are transforming the way Merck operates and executes, our fundamental strategy has remained consistent. Our success and our future will continue to be predicated on innovating at the intersection of scientific opportunity and global unmet medical need. This is the best pathway to sustainable, long-term growth,” continued Frazier.

 

Worldwide sales were $10.5 billion for the fourth quarter of 2014, a decrease of 7 percent compared with the fourth quarter of 2013, including a 3 percent negative impact from foreign exchange and a 7 percent negative impact from patent expiries and divestitures, including the Consumer Care business. Full-year 2014 worldwide sales were $42.2 billion, a decrease of 4 percent compared with the full year of 2013, including a 1 percent negative impact from foreign exchange and a 4 percent negative impact from patent expiries and divestitures, including the Consumer Care business.

 

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

 

Fourth
Quarter
2014

 

Fourth
Quarter
2013

 

Change

 

Change
Ex-
Exchange

 

Year
Ended
Dec. 31,
2014

 

Year
Ended
Dec. 31,
2013

 

Change

 

Change
Ex-
Exchange

 

Total Sales

 

$

10,482

 

$

11,319

 

-7

%

-4

%

$

42,237

 

$

44,033

 

-4

%

-3

%

Pharmaceutical

 

9,370

 

9,760

 

-4

%

0

%

36,042

 

37,437

 

-4

%

-2

%

JANUVIA/ JANUMET

 

1,652

 

1,624

 

2

%

6

%

6,002

 

5,833

 

3

%

4

%

ZETIA/ VYTORIN

 

1,032

 

1,152

 

-10

%

-7

%

4,166

 

4,300

 

-3

%

-2

%

REMICADE

 

557

 

620

 

-10

%

-3

%

2,372

 

2,271

 

4

%

4

%

GARDASIL

 

356

 

394

 

-10

%

-6

%

1,738

 

1,831

 

-5

%

-3

%

ISENTRESS

 

418

 

442

 

-5

%

-1

%

1,673

 

1,643

 

2

%

3

%

PROQUAD, M-M-R II and VARIVAX

 

366

 

273

 

34

%

36

%

1,394

 

1,306

 

7

%

8

%

NASONEX

 

268

 

327

 

-18

%

-15

%

1,099

 

1,335

 

-18

%

-16

%

SINGULAIR

 

319

 

298

 

7

%

16

%

1,092

 

1,196

 

-9

%

-4

%

Animal Health

 

885

 

871

 

2

%

8

%

3,454

 

3,362

 

3

%

5

%

Consumer Care

 

16

 

390

 

-96

%

-96

%

1,547

 

1,894

 

-18

%

-17

%

Other Revenues

 

211

 

298

 

-29

%

-63

%

1,194

 

1,340

 

-11

%

-24

%

 

Commercial and Pipeline Highlights

 

·                  The company continued to make steady progress in advancing its late-stage pipeline, and received U.S. approval for six new products in 2014 that are launching in 2015,

 

Page 3



 

including novel medicines KEYTRUDA (pembrolizumab) for the treatment of advanced melanoma in patients whose disease has progressed after other therapies and BELSOMRA (suvorexant) for the treatment of insomnia.

 

·                  Additionally, as part of its acquisition of Cubist Pharmaceuticals, Inc. (Cubist), the company acquired ZERBAXA (ceftolozane/tazobactam), an antibiotic approved by the U.S. Food and Drug Administration (FDA) in December 2014 to treat Gram-negative bacteria, a key cause of in-hospital infections. The company is preparing to launch ZERBAXA immediately in the United States.

 

·                  Merck continued to accelerate its KEYTRUDA program.

 

·                  In September 2014, the FDA granted approval of KEYTRUDA, the first FDA-approved anti-PD-1 therapy. An estimated 2,000 patients were receiving treatment with KEYTRUDA in December 2014.

·                  KEYTRUDA received Breakthrough Therapy Designation from the FDA for advanced non-small cell lung cancer (NSCLC) in 2014. Last month, the company announced that it expects to submit a supplemental Biologics License Application in mid-year 2015 to the FDA for KEYTRUDA for the treatment of patients with Epidermal Growth Factor Receptor (EGFR) mutation-negative and Anaplastic Lymphoma Kinase (ALK) rearrangement-negative NSCLC whose disease has progressed on or following platinum-containing chemotherapy.

·                  KEYTRUDA continues to be studied in more than 30 cancers and in 20 combination settings, and Merck has presented data in a number of different tumor types.

 

·                  The company accelerated its hepatitis C virus (HCV) clinical development program in 2014.

 

·                  Merck recently announced that it expects to file a New Drug Application (NDA) with the FDA in the first half of 2015 for grazoprevir/elbasvir (MK-5172/MK-8742), the company’s investigational oral, once-daily combination regimen for the treatment of chronic HCV infection.

·                  On Jan. 30, 2015, the company received notification from the FDA of its intent to rescind Breakthrough Therapy Designation status for this combination treatment regimen, citing the availability of other recently approved treatments for Genotype 1 patients. The company expects to discuss this matter with the FDA and does not expect that it will impact its ability to file an NDA for this combination regimen or the timing of that filing.

 

Page 4



 

·                  The company has started the Phase 2 C-CREST studies to study combination regimens of grazoprevir and MK-3682 (formerly IDX21437) with either elbasvir or MK-8408 for the treatment of HCV infection. The company expects to begin Phase 3 studies in 2015.

 

·                  The company continued to build upon its legacy and leadership in vaccines with the approval of GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant), which was approved by the FDA in December 2014 to prevent cancers and other diseases caused by nine HPV types.

 

·                  The company anticipates an FDA advisory committee meeting will be held in the first quarter of 2015 to review BRIDION (sugammadex), an investigational agent for the reversal of neuromuscular blockade induced by rocuronium or vecuronium. If approved, the company expects to launch BRIDION later in 2015.

 

·                  The company strengthened its antibiotics portfolio by acquiring Cubist; its hepatitis pipeline by acquiring Idenix Pharmaceuticals, Inc.; and its oncology pipeline by acquiring OncoEthix.

 

Pharmaceutical Revenue Performance

 

Fourth-quarter pharmaceutical sales declined 4 percent to $9.4 billion, including a 4 percent negative impact from foreign exchange and a 3 percent negative impact reflecting approximately $200 million of lower sales from patent expiries and product divestitures. Also contributing to the decline were lower sales of ZETIA (ezetimibe)/VYTORIN (ezetimibe/ simvastatin), medicines for lowering LDL cholesterol; the HCV portfolio of VICTRELIS (boceprevir) and PEGINTRON (peginterferon alfa-2b); and REMICADE (infliximab), a treatment for inflammatory diseases. These declines were partially offset by growth in the four core therapeutic areas of vaccines, diabetes, hospital acute care and oncology. The growth in oncology reflects the launch of KEYTRUDA whose sales were $50 million in the fourth quarter of 2014. Full-year 2014 pharmaceutical sales declined 4 percent to $36.0 billion, including a 2 percent negative impact from foreign exchange and a 3 percent negative impact from patent expiries and product divestitures.

 

Animal Health Revenue Performance

 

Animal Health sales totaled $885 million for the fourth quarter of 2014, an increase of 2 percent compared with the fourth quarter of 2013, including a 6 percent negative impact from foreign exchange. Growth was driven by increases across most species. In companion animals, growth was supported by the global launch of BRAVECTO (fluralaner), a chewable tablet that kills fleas and ticks in dogs for up to 12 weeks. Worldwide sales for the full year of 2014 were

 

Page 5



 

$3.5 billion, an increase of 3 percent, including a 2 percent negative impact from foreign exchange. Full-year 2014 results reflect the company’s decision in the third quarter of 2013 to voluntarily suspend the sale of ZILMAX (zilpaterol hydrochloride), a feed supplement for beef cattle, in the United States and Canada. Excluding ZILMAX, full-year 2014 sales grew 7 percent, including a 2 percent negative impact from foreign exchange.

 

Other Revenue Performance

 

Other revenues — primarily comprising alliance revenue, miscellaneous corporate revenues and third-party manufacturing sales — decreased 29 percent to $211 million compared to the fourth quarter of 2013. The decrease was driven primarily by the loss of revenue from AstraZeneca (AZ) recorded by Merck, which was $193 million in the fourth quarter of 2013. On June 30, 2014, AZ exercised its option to buy the company’s interest in a subsidiary and, through it, the company’s interest in Nexium and Prilosec. Other revenues decreased 11 percent to $1.2 billion for the full year of 2014.

 

Fourth-Quarter and Full-Year 2014 Expense and Other Information

 

The costs detailed below totaled $9.3 billion on a GAAP basis during the fourth quarter of 2014 and include $2.0 billion of acquisition- and divestiture-related costs and restructuring costs and certain other items.

 

 

 

Included in expenses for the period

 

$ in millions

 

GAAP

 

Acquisition- and
Divestiture-
Related
Costs
(4)

 

Restructuring
Costs

 

Non-GAAP(1)

 

Fourth Quarter 2014

 

 

 

 

 

 

 

 

 

Materials and production

 

$

3,749

 

$

984

 

$

105

 

$

2,660

 

Marketing and administrative

 

2,924

 

81

 

57

 

2,786

 

Research and development

 

2,283

 

329

 

108

 

1,846

 

Restructuring costs

 

349

 

 

349

 

 

 

 

 

 

 

 

 

 

 

 

Fourth Quarter 2013

 

 

 

 

 

 

 

 

 

Materials and production

 

$

4,607

 

$

1,301

 

$

253

 

$

3,053

 

Marketing and administrative

 

2,982

 

32

 

81

 

2,869

 

Research and development

 

1,836

 

15

 

63

 

1,758

 

Restructuring costs

 

565

 

 

565

 

 

 

The costs detailed below totaled $36.6 billion on a GAAP basis for the full year of 2014 and include $8.0 billion of acquisition-related costs and restructuring costs and certain other items.

 

Page 6



 

 

 

Included in expenses for the period

 

$ in millions

 

GAAP

 

Acquisition- and
Divestiture-
Related
Costs
(4)

 

Restructuring
Costs

 

Certain
Other Items

 

Non-GAAP(1)

 

Year Ended Dec. 31, 2014

 

 

 

 

 

 

 

 

 

 

 

Materials and production

 

$

16,768

 

$

5,254

 

$

482

 

$

 

$

11,032

 

Marketing and administrative

 

11,606

 

234

 

200

 

193

 

10,979

 

Research and development

 

7,180

 

365

 

283

 

 

6,532

 

Restructuring costs

 

1,013

 

 

1,013

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Year Ended Dec. 31, 2013

 

 

 

 

 

 

 

 

 

 

 

Materials and production

 

$

16,954

 

$

5,176

 

$

446

 

$

 

$

11,332

 

Marketing and administrative

 

11,911

 

94

 

145

 

 

11,672

 

Research and development

 

7,503

 

279

 

101

 

 

7,123

 

Restructuring costs

 

1,709

 

 

1,709

 

 

 

 

The gross margin was 64.2 percent for the fourth quarter of 2014 compared to 59.3 percent for the fourth quarter of 2013, reflecting 10.4 and 13.7 unfavorable percentage point impacts, respectively, from the acquisition- and divestiture-related costs and restructuring costs noted above. The gross margin was 60.3 percent for the full year of 2014 compared to 61.5 percent for the full year of 2013, reflecting 13.6 and 12.8 unfavorable percentage point impacts, respectively, from the acquisition- and divestiture-related costs and restructuring costs noted above.

 

Marketing and administrative expenses, on a non-GAAP basis, were $2.8 billion in the fourth quarter of 2014, a decrease from $2.9 billion in the same period of 2013, which was primarily driven by the sale of the Consumer Care business. Full-year marketing and administrative expenses in 2014, on a non-GAAP basis, were $11.0 billion, a decrease from $11.7 billion in 2013. The declines were primarily due to productivity measures and divestitures.

 

R&D expenses, on a non-GAAP basis, were $1.8 billion in the fourth quarter of 2014, a 5 percent increase compared to the fourth quarter of 2013. Full-year R&D expenses in 2014, on a non-GAAP basis, were $6.5 billion, a decrease from $7.1 billion in 2013. The full-year decline reflects targeted cost reductions and lower clinical development spending resulting from portfolio prioritization.

 

Other (income) expense, net, was $10.6 billion of income in the fourth quarter of 2014 compared to $157 million of expense in the fourth quarter of 2013. Other (income) expense, net, was $11.4 billion of income for the full year of 2014 compared to $815 million of expense for the full year of 2013. Other (income) expense, net in the fourth quarter and full year of 2014 includes an $11.2 billion gain on the divestiture of the Consumer Care business and a $628 million loss on the extinguishment of debt.

 

Page 7



 

The GAAP effective tax rates of 38.0 percent for the fourth quarter of 2014 and 30.9 percent for the full year of 2014 reflect the impacts of acquisition- and divestiture-related costs, restructuring costs and certain other items, including the impact of the gain on the divestiture of the Consumer Care business being taxed primarily at combined U.S. federal and state tax rates. The non-GAAP effective tax rates, which exclude these items, were 20.0 percent for the fourth quarter and 24.3 percent for the full year of 2014. Both the GAAP and non-GAAP effective tax rates for the fourth quarter and full year of 2014 include the favorable impact of tax legislation enacted in the fourth quarter of 2014.

 

Financial Outlook

 

Merck expects its full-year 2015 non-GAAP EPS range to be between $3.32 and $3.47, including a $0.27 negative impact from foreign exchange. The range excludes acquisition- and divestiture-related costs and costs related to restructuring programs. Merck expects its full-year 2015 GAAP EPS range to be between $1.62 and $1.91.

 

At mid-January 2015 exchange rates, Merck anticipates full-year 2015 revenues to be between $38.3 billion and $39.8 billion, including a $2.6 billion negative impact from foreign exchange and approximately $1 billion of net lost sales from acquisitions and divestitures.

 

In addition, the company expects full-year 2015 non-GAAP marketing and administrative expenses to be below 2014 levels and R&D expenses to be modestly above 2014 levels.

 

The company anticipates its full-year 2015 non-GAAP tax rate will be in the range of 22 to 23 percent, not including a 2015 R&D tax credit.

 

A reconciliation of anticipated 2015 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
2015

 

GAAP EPS

 

$1.62 to $1.91

 

Difference(3)

 

1.70 to 1.56

 

Non-GAAP EPS that excludes items listed below

 

$3.32 to $3.47

 

 

 

 

 

Acquisition- and divestiture-related costs

 

$5,000 to $4,700

 

Restructuring costs

 

950 to 750

 

Net decrease (increase) in income before taxes

 

5,950 to 5,450

 

Estimated income tax (benefit) expense

 

(1,100) to (1,000)

 

Decrease (increase) in net income

 

$4,850 to $4,450

 

 

Total Employees

 

As of Dec. 31, 2014, Merck had approximately 70,000 employees worldwide, including the company’s joint ventures in China and Brazil.

 

Page 8



 

Earnings Conference Call

 

Investors, journalists and the general public may access a live audio webcast of the call today at 8:00 a.m. EST 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 54622693. Members of the media are invited to monitor the call by dialing (706) 758-9928 or (800) 399-7917 and using ID code number 54622693. 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 health care 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 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 health care through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube. You can also follow our Twitter conversation at $MRK.

 

Forward-Looking Statement

 

This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. 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

 

Page 9



 

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 2013 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

 

###

 

Page 10



 

MERCK & CO., INC.

CONSOLIDATED STATEMENT OF INCOME - GAAP

(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)

(UNAUDITED)

Table 1

 

 

 

 

 

 

 

GAAP

 

 

 

 

 

GAAP

 

 

 

Dec YTD

 

Dec YTD

 

 

 

 

 

4Q14

 

4Q13

 

% Change

 

2014

 

2013

 

% Change

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sales

 

$

10,482

 

$

11,319

 

-7

%

$

42,237

 

$

44,033

 

-4

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Costs, Expenses and Other

 

 

 

 

 

 

 

 

 

 

 

 

 

Materials and production (1)

 

3,749

 

4,607

 

-19

%

16,768

 

16,954

 

-1

%

Marketing and administrative (1)

 

2,924

 

2,982

 

-2

%

11,606

 

11,911

 

-3

%

Research and development (1)

 

2,283

 

1,836

 

24

%

7,180

 

7,503

 

-4

%

Restructuring costs (2)

 

349

 

565

 

-38

%

1,013

 

1,709

 

-41

%

Equity income from affiliates (3)

 

(16

)

(53

)

-70

%

(257

)

(404

)

-36

%

Other (income) expense, net (1) (4)

 

(10,618

)

157

 

*

 

(11,356

)

815

 

*

 

Income Before Taxes

 

11,811

 

1,225

 

*

 

17,283

 

5,545

 

*

 

Income Tax Provision

 

4,484

 

410

 

 

 

5,349

 

1,028

 

 

 

Net Income

 

7,327

 

815

 

*

 

11,934

 

4,517

 

*

 

Less: Net Income Attributable to Noncontrolling Interests

 

11

 

34

 

 

 

14

 

113

 

 

 

Net Income Attributable to Merck & Co., Inc.

 

$

7,316

 

$

781

 

*

 

$

11,920

 

$

4,404

 

*

 

Earnings per Common Share Assuming Dilution

 

$

2.54

 

$

0.26

 

*

 

$

4.07

 

$

1.47

 

*

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Average Shares Outstanding Assuming Dilution

 

2,880

 

2,959

 

 

 

2,928

 

2,996

 

 

 

Tax Rate (5)

 

38.0

%

33.5

%

 

 

30.9

%

18.5

%

 

 

 

* 100% or greater

 

(1) Amounts include the impact of acquisition and divestiture-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) Reflects the performance of the company’s joint ventures and other equity method affiliates, including the Sanofi Pasteur MSD partnership, as well as the AstraZeneca LP partnership until its termination on June 30, 2014.

 

(4) Other (income) expense, net in the fourth quarter and full year of 2014 includes an $11.2 billion gain on the divestiture of Merck’s Consumer Care business and a $628 million loss on the extinguishment of debt.  In addition, other (income) expense, net for the full year of 2014 includes a gain of $741 million related to AstraZeneca’s option exercise, gains of $480 million on the divestiture of certain ophthalmic products in several international markets, and gains of $204 million related to the divestiture of the company’s Sirna Therapeutics, Inc. subsidiary, as well as a $93 million goodwill impairment charge related to the company’s joint venture with Supera Farma Laboratorios S.A.  Other (income) expense, net in 2013 reflects approximately $140 million of exchange losses as a result of a Venezuelan currency devaluation.

 

(5)  The effective income tax rates for the fourth quarter and full year of 2014 include the impact of the gain on the divestiture of Merck’s Consumer Care business being taxed primarily at combined U.S. federal and state tax rates.  The effective income tax rates for the fourth quarter and full year of 2014 also reflect the favorable impact of tax legislation enacted in the fourth quarter of 2014.  In addition, the effective income tax rate for the full year of 2014 reflects a net benefit of $517 million recorded in connection with AstraZeneca’s option exercise, as well as a benefit of approximately $300 million associated with a capital loss generated in the first quarter of 2014. 

 

The effective income tax rate for the full year of 2013 reflects net benefits from the settlements of certain federal income tax issues, reductions in tax reserves upon expiration of applicable statute of limitations and the favorable impact of tax legislation enacted in the first quarter of 2013.

 



 

MERCK & CO., INC.

CONSOLIDATED STATEMENT OF INCOME

GAAP TO NON-GAAP RECONCILIATION

FOURTH QUARTER 2014

(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)

(UNAUDITED)

Table 2a

 

 

 

GAAP

 

Acquisition and
Divestiture-
Related Costs 
(1)

 

Restructuring
Costs 
(2)

 

Certain Other
Items 
(3)

 

Adjustment
Subtotal

 

Non-GAAP

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sales

 

$

10,482

 

 

 

 

 

 

 

 

 

$

10,482

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Costs, Expenses and Other

 

 

 

 

 

 

 

 

 

 

 

 

 

Materials and production

 

3,749

 

984

 

105

 

 

 

1,089

 

2,660

 

Marketing and administrative

 

2,924

 

81

 

57

 

 

 

138

 

2,786

 

Research and development

 

2,283

 

329

 

108

 

 

 

437

 

1,846

 

Restructuring costs

 

349

 

 

 

349

 

 

 

349

 

 

Equity income from affiliates

 

(16

)

 

 

 

 

 

 

 

 

(16

)

Other (income) expense, net

 

(10,618

)

 

 

 

 

(10,679

)

(10,679

)

61

 

Income Before Taxes

 

11,811

 

(1,394

)

(619

)

10,679

 

8,666

 

3,145

 

Taxes on Income

 

4,484

 

 

 

 

 

 

 

3,854

(4)

630

 

Net Income

 

7,327

 

 

 

 

 

 

 

4,812

 

2,515

 

Less: Net Income Attributable to Noncontrolling Interests

 

11

 

 

 

 

 

 

 

 

 

11

 

Net Income Attributable to Merck & Co., Inc.

 

$

7,316

 

 

 

 

 

 

 

$

4,812

 

$

2,504

 

Earnings per Common Share Assuming Dilution

 

$

2.54

 

 

 

 

 

 

 

 

 

$

0.87

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Average Shares Outstanding Assuming Dilution

 

2,880

 

 

 

 

 

 

 

 

 

2,880

 

Tax Rate

 

38.0

%

 

 

 

 

 

 

 

 

20.0

%

 

Merck is providing non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing this information enhances investors’ understanding of the company’s performance.  This information should be considered in addition to, but not in lieu of, information prepared in accordance with GAAP.

 

(1) Amounts included in materials and production costs reflect expenses for the amortization of intangible assets recognized as a result of mergers and acquisitions.  Amounts included in marketing and administrative expenses reflect merger integration costs, as well as transaction and certain other costs related to business acquisitions and divestitures.  Amounts included in research and development expenses reflect a $316 million charge resulting from an increase in the fair value of a liability for contingent consideration, as well as in-process research and development (“IPR&D”) impairment charges of $13 million. 

 

(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) Included in other (income) expense, net is an $11.2 billion gain on the divestiture of Merck’s Consumer Care business, an additional gain of $84 million on the divestiture of certain ophthalmic products in several international markets and a $628 million loss on the extinguishment of debt.

 

(4) Represents the estimated tax impact on the reconciling items.

 



 

MERCK & CO., INC.

CONSOLIDATED STATEMENT OF INCOME

GAAP TO NON-GAAP RECONCILIATION

FULL YEAR 2014

(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)

(UNAUDITED)

Table 2b

 

 

 

 

 

Acquisition and

 

 

 

 

 

 

 

 

 

 

 

 

 

Divestiture-

 

Restructuring

 

Certain Other

 

Adjustment

 

 

 

 

 

GAAP

 

Related Costs (1)

 

Costs (2)

 

Items (3)

 

Subtotal

 

Non-GAAP

 

Sales

 

$

42,237

 

 

 

 

 

 

 

 

 

$

42,237

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Costs, Expenses and Other

 

 

 

 

 

 

 

 

 

 

 

 

 

Materials and production

 

16,768

 

5,254

 

482

 

 

 

5,736

 

11,032

 

Marketing and administrative

 

11,606

 

234

 

200

 

193

 

627

 

10,979

 

Research and development

 

7,180

 

365

 

283

 

 

 

648

 

6,532

 

Restructuring costs

 

1,013

 

 

 

1,013

 

 

 

1,013

 

 

Equity income from affiliates

 

(257

)

 

 

 

 

 

 

 

 

(257

)

Other (income) expense, net

 

(11,356

)

93

 

 

 

(11,811

)

(11,718

)

362

 

Income Before Taxes

 

17,283

 

(5,946

)

(1,978

)

11,618

 

3,694

 

13,589

 

Taxes on Income

 

5,349

 

 

 

 

 

 

 

2,045

(4)

3,304

 

Net Income

 

11,934

 

 

 

 

 

 

 

1,649

 

10,285

 

Less: Net Income Attributable to Noncontrolling Interests

 

14

 

(56

)

 

 

 

 

(56

)

70

 

Net Income Attributable to Merck & Co., Inc.

 

$

11,920

 

 

 

 

 

 

 

$

1,705

 

$

10,215

 

Earnings per Common Share Assuming Dilution

 

$

4.07

 

 

 

 

 

 

 

 

 

$

3.49

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Average Shares Outstanding Assuming Dilution

 

2,928

 

 

 

 

 

 

 

 

 

2,928

 

Tax Rate

 

30.9

%

 

 

 

 

 

 

 

 

24.3

%

 

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 of $4.2 billion for the amortization of intangible assets recognized as a result of mergers and acquisitions, as well as $1.1 billion of impairment charges on product intangibles.  Amounts included in marketing and administrative expenses reflect merger integration costs, as well as transaction and certain other costs related to business acquisitions and divestitures.  Amounts included in research and development expenses reflect a charge of $316 million resulting from an increase in the fair value of a liability for contingent consideration, as well as in-process research and development (“IPR&D”) impairment charges of $49 million primarily related to the company’s joint venture with Supera.  Amount included in other (income) expense, net represents a goodwill impairment charge related to the joint venture with Supera.  Amount included in net income attributable to non-controlling interests represents the portion of intangible asset and goodwill impairment charges related to the joint venture with Supera that are attributable to non-controlling interests.

 

(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) Amount included in marketing and administrative expenses represents an additional year of expense related to the healthcare reform fee in accordance with final regulations issued in the third quarter by the Internal Revenue Service.  Included in other (income) expense, net is an $11.2 billion gain on the divestiture of Merck’s Consumer Care business, a $741 million gain related to AstraZeneca’s option exercise, gains of $480 million on the divestiture of certain ophthalmic products in several international markets and a $628 million loss on the extinguishment of debt.

 

(4) Represents the estimated tax impact on the reconciling items, including a net benefit of approximately $517 million recorded in connection with AstraZeneca’s option exercise, as well as a benefit of approximately $300 million associated with a capital loss generated in the first quarter.

 


 


 

MERCK & CO., INC.
FRANCHISE / KEY PRODUCT SALES
(AMOUNTS IN MILLIONS)
Table 3

 

 

 

2014

 

2013

% Change

 

% Change

 

 

 

1Q

 

2Q

 

3Q

 

4Q

 

Full Year

 

1Q

 

2Q

 

3Q

 

4Q

 

Full Year

 

4Q

 

Full Year

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

TOTAL SALES (1)

 

$

10,264

 

$

10,934

 

$

10,557

 

$

10,482

 

$

42,237

 

$

10,671

 

$

11,010

 

$

11,032

 

$

11,319

 

$

44,033

 

-7

 

-4

 

PHARMACEUTICAL

 

8,451

 

9,087

 

9,134

 

9,370

 

36,042

 

8,891

 

9,310

 

9,475

 

9,760

 

37,437

 

-4

 

-4

 

Primary Care and Women’s Health

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cardiovascular

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Zetia

 

611

 

717

 

660

 

662

 

2,650

 

629

 

650

 

662

 

716

 

2,658

 

-8

 

0

 

Vytorin

 

361

 

417

 

369

 

370

 

1,516

 

394

 

417

 

396

 

436

 

1,643

 

-15

 

-8

 

Diabetes

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Januvia

 

858

 

1,058

 

933

 

1,082

 

3,931

 

884

 

1,072

 

927

 

1,121

 

4,004

 

-3

 

-2

 

Janumet

 

476

 

519

 

505

 

570

 

2,071

 

409

 

474

 

442

 

503

 

1,829

 

13

 

13

 

General Medicine & Women’s Health

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NuvaRing

 

168

 

178

 

186

 

191

 

723

 

151

 

171

 

170

 

193

 

686

 

-1

 

5

 

Implanon / Nexplanon

 

102

 

119

 

158

 

123

 

502

 

84

 

102

 

96

 

120

 

403

 

2

 

25

 

Dulera

 

102

 

103

 

124

 

132

 

460

 

68

 

79

 

82

 

95

 

324

 

39

 

42

 

Follistim AQ

 

110

 

102

 

97

 

102

 

412

 

122

 

134

 

124

 

101

 

481

 

1

 

-14

 

Hospital and Specialty

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Hepatitis

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Peglntron

 

112

 

103

 

84

 

81

 

381

 

126

 

142

 

104

 

124

 

496

 

-34

 

-23

 

Victrelis

 

59

 

46

 

27

 

21

 

153

 

110

 

116

 

121

 

81

 

428

 

-74

 

-64

 

HIV

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Isentress

 

390

 

453

 

412

 

418

 

1,673

 

362

 

412

 

427

 

442

 

1,643

 

-5

 

2

 

Acute Care

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cancidas

 

166

 

156

 

183

 

175

 

681

 

162

 

163

 

151

 

183

 

660

 

-4

 

3

 

Invanz

 

114

 

134

 

141

 

139

 

529

 

110

 

120

 

130

 

128

 

488

 

9

 

8

 

Noxafil

 

74

 

98

 

107

 

122

 

402

 

65

 

71

 

75

 

98

 

309

 

25

 

30

 

Bridion

 

73

 

82

 

90

 

95

 

340

 

63

 

69

 

75

 

82

 

288

 

15

 

18

 

Primaxin

 

71

 

81

 

91

 

86

 

329

 

84

 

85

 

88

 

79

 

335

 

9

 

-2

 

Immunology

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Remicade

 

604

 

607

 

604

 

557

 

2,372

 

549

 

527

 

574

 

620

 

2,271

 

-10

 

4

 

Simponi

 

157

 

174

 

170

 

188

 

689

 

108

 

120

 

126

 

146

 

500

 

29

 

38

 

Other

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cosopt / Trusopt

 

99

 

100

 

34

 

25

 

257

 

105

 

103

 

104

 

103

 

416

 

-76

 

-38

 

Oncology

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Emend

 

122

 

144

 

136

 

151

 

553

 

116

 

135

 

123

 

134

 

507

 

13

 

9

 

Temodar

 

83

 

93

 

88

 

86

 

350

 

216

 

219

 

162

 

111

 

708

 

-23

 

-51

 

Keytruda

 

0

 

0

 

4

 

50

 

55

 

0

 

0

 

0

 

0

 

0

 

*

 

*

 

Diversified Brands

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Respiratory

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Nasonex

 

312

 

258

 

261

 

268

 

1,099

 

385

 

325

 

297

 

327

 

1,335

 

-18

 

-18

 

Singulair

 

271

 

284

 

218

 

319

 

1,092

 

337

 

281

 

280

 

298

 

1,196

 

7

 

-9

 

Clarinex

 

62

 

69

 

49

 

52

 

232

 

61

 

64

 

54

 

55

 

235

 

-6

 

-1

 

Other

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cozaar / Hyzaar

 

205

 

214

 

195

 

192

 

806

 

267

 

255

 

238

 

246

 

1,006

 

-22

 

-20

 

Arcoxia

 

128

 

141

 

132

 

118

 

519

 

121

 

121

 

112

 

131

 

484

 

-9

 

7

 

Fosamax

 

123

 

121

 

114

 

112

 

470

 

137

 

144

 

140

 

139

 

560

 

-20

 

-16

 

Propecia

 

74

 

58

 

66

 

67

 

264

 

68

 

67

 

71

 

77

 

283

 

-13

 

-7

 

Zocor

 

64

 

69

 

61

 

64

 

258

 

82

 

74

 

65

 

79

 

301

 

-19

 

-14

 

Remeron

 

50

 

40

 

47

 

56

 

193

 

52

 

53

 

44

 

56

 

206

 

-1

 

-6

 

Vaccines

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Gardasil

 

383

 

409

 

590

 

356

 

1,738

 

390

 

383

 

665

 

394

 

1,831

 

-10

 

-5

 

ProQuad, M-M-R II and Varivax

 

280

 

326

 

421

 

366

 

1,394

 

272

 

339

 

421

 

273

 

1,306

 

34

 

7

 

Zostavax

 

142

 

156

 

181

 

285

 

765

 

168

 

141

 

185

 

264

 

758

 

8

 

1

 

Pneumovax 23

 

101

 

102

 

197

 

346

 

746

 

111

 

108

 

193

 

241

 

653

 

44

 

14

 

RotaTeq

 

169

 

147

 

174

 

169

 

659

 

162

 

144

 

201

 

129

 

636

 

31

 

4

 

Other Pharmaceutical (2)

 

1,175

 

1,209

 

1,225

 

1,174

 

4,778

 

1,361

 

1,430

 

1,350

 

1,435

 

5,570

 

-18

 

-14

 

ANIMAL HEALTH

 

813

 

872

 

885

 

885

 

3,454

 

840

 

851

 

800

 

871

 

3,362

 

2

 

3

 

CONSUMER CARE (3)

 

546

 

583

 

401

 

16

 

1,547

 

571

 

490

 

443

 

390

 

1,894

 

-96

 

-18

 

Claritin OTC

 

170

 

153

 

110

 

1

 

434

 

177

 

78

 

123

 

92

 

471

 

-99

 

-8

 

Other Revenues (4)

 

454

 

392

 

137

 

211

 

1,194

 

369

 

359

 

314

 

298

 

1,340

 

-29

 

-11

 

Astra

 

147

 

316

 

1

 

0

 

465

 

262

 

245

 

220

 

193

 

920

 

*

 

-50

 

 

* 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 $98 million, $76 million, $116 million and $88 million for the first, second, third and fourth quarters of 2014, respectively. Other Vaccines sales included in Other Pharmaceutical were $53 million, $86 million, $127 million, and $101 million for the first, second, third, and fourth quarters of 2013, respectively.

 

(3) On October 1, 2014, the company divested the Consumer Care business to Bayer. Fourth quarter 2014 reflect sales in Mexico and Korea. These markets had not yet received regulatory approval of the divestiture.

 

(4) Other revenues are comprised primarily of alliance revenue, third-party manufacturing sales and miscellaneous corporate revenues, including revenue hedging activities. On October 1, 2013, the company divested a substantial portion of its third-party manufacturing sales. On June 30, 2014, AstraZeneca exercised its option to buy Merck’s interest in a subsidiary and through it, Merck’s interest in Nexium and Prilosec. As a result, the company no longer records supply sales for these products. In addition, Other revenues in the fourth quarter and full year of 2013 reflect $50 million of revenue for the out-license of a pipeline compound.