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EX-99.2 - EX-99.2 - Merck & Co., Inc.a17-12140_1ex99d2.htm
8-K - 8-K - 1Q EARNINGS REPORT - Merck & Co., Inc.a17-12140_18k.htm

Exhibit 99.1

 

GRAPHIC

 

News Release

 

FOR IMMEDIATE RELEASE

 

Media Contact:

 

Tracy Ogden

 

Investor Contacts:

 

Teri Loxam

 

 

(908) 740-1747

 

 

 

(908) 740-1986

 

 

 

 

 

 

 

 

 

 

 

 

 

Amy Klug

 

 

 

 

 

 

(908) 740-1898

 

Merck Announces First-Quarter 2017 Financial Results

 

·                  First-Quarter 2017 Worldwide Sales Were $9.4 Billion, an Increase of 1 Percent, Including a 2 Percent Negative Impact from Foreign Exchange

 

·                  First-Quarter 2017 GAAP EPS Was $0.56; First-Quarter Non-GAAP EPS Was $0.88

 

·                  Company Narrows and Raises 2017 Full-Year Revenue Range to be Between $39.1 Billion and $40.3 Billion, Including an Approximately 1.5 Percent Negative Impact from Foreign Exchange

 

·                  Company Narrows and Raises 2017 Full-Year GAAP EPS Range to be Between $2.51 and $2.63; Narrows and Raises 2017 Full-Year Non-GAAP EPS Range to be Between $3.76 and $3.88, Including an Approximately 1.5 Percent Negative Impact from Foreign Exchange

 

·                  KEYTRUDA Development Program Advances with Two Additional Regulatory Approvals and CHMP Positive Opinion; Four sBLAs Currently Under Priority Review with PDUFA Action Dates in Second Quarter

 

KENILWORTH, N.J., May 2, 2017 — Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the first quarter of 2017.

 

“Merck delivered solid performance across our broad range of products that address major disease categories and the needs of global health,” said Kenneth C. Frazier, chairman and chief executive officer, Merck. “The continued momentum of KEYTRUDA in oncology, along with the strength of the vaccine and other franchises and animal health, helped to drive revenue growth in the quarter.”

 



 

Financial Summary

 

 

 

First Quarter

 

$ in millions, except EPS amounts

 

2017

 

2016

 

Sales

 

$9,434

 

$9,312

 

GAAP EPS

 

0.56

 

0.40

 

Non-GAAP EPS that excludes certain items1*

 

0.88

 

0.89

 

GAAP net income2

 

1,551

 

1,125

 

Non-GAAP net income that excludes certain items1,2*

 

2,437

 

2,492

 

 

*Refer to table on page 7.

 

Worldwide sales were $9.4 billion for the first quarter of 2017, an increase of 1 percent compared with the first quarter of 2016, including a 2 percent negative impact from foreign exchange.

 

GAAP (generally accepted accounting principles) earnings per share assuming dilution (EPS) were $0.56 for the first quarter of 2017. Non-GAAP EPS of $0.88 for the first quarter of 2017 excludes acquisition- and divestiture-related costs, restructuring costs and certain other items.

 

Pipeline Highlights

 

Merck continued to deliver significant progress in the development program for KEYTRUDA (pembrolizumab), an anti-PD-1 therapy, receiving key regulatory approvals or opinions and supplemental Biologics License Application (sBLA) acceptances.

 

·                  The U.S. Food and Drug Administration (FDA) approved under its Accelerated Approval program KEYTRUDA for the treatment of patients with refractory classical Hodgkin lymphoma (cHL) or for patients with cHL who have relapsed after three or more prior lines of therapy.

 

·                  The European Commission approved KEYTRUDA for the first-line treatment of non-small cell lung cancer (NSCLC) in adults whose tumors have high PD-L1 expression (tumor proportion score of 50 percent or more) with no EGFR or ALK positive tumor mutations.

 

·                  The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of KEYTRUDA for the treatment of adult patients with relapsed or refractory cHL who have failed autologous

 


1  Merck is providing certain 2017 and 2016 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 results as it permits investors to understand how management assesses performance. Management uses these measures internally for planning and forecasting purposes and to measure the performance of the company along with other metrics. Senior management’s annual compensation is derived in part using non-GAAP income and non-GAAP EPS. This information should be considered in addition to, but not as a substitute for or superior to, information prepared in accordance with GAAP. For a description of the items, see Table 2a attached to this release.

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

 

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stem cell transplant and brentuximab vedotin (BV), or who are transplant-ineligible and have failed BV.

 

·                  The FDA accepted for review under its Accelerated Approval program the sBLA for KEYTRUDA in combination with pemetrexed and carboplatin for the treatment of patients with metastatic or advanced NSCLC regardless of PD-L1 expression. This is the first application for regulatory approval of KEYTRUDA in combination with another treatment. The FDA granted Priority Review with a PDUFA action date of May 10, 2017.

 

·                  The FDA accepted and granted Priority Review for the sBLA for the treatment of patients with locally advanced or metastatic urothelial cancer, a type of bladder cancer, for first-line use in patients who are ineligible for cisplatin-containing therapy. The application for second-line use was also accepted for Priority Review. The PDUFA action date for both applications is June 14, 2017.

 

·                  The company recently submitted additional data and analyses to the FDA for the pending sBLA application for the treatment of previously treated patients with advanced microsatellite instability-high cancer. The PDUFA action date for this Priority Review has been extended to June 9, 2017.

 

The FDA and EMA accepted for review three New Drug Applications (NDAs) in the company’s diabetes franchise for medicines containing ertugliflozin, an investigational SGLT2 inhibitor in development to help improve glycemic control in adults with type 2 diabetes as part of Merck’s collaboration with Pfizer Inc. The PDUFA action date from the FDA is in December 2017 for the three NDAs.

 

Merck presented phase 3 data across our late-stage pipeline in studies that met their primary endpoints.

 

·                  At the Conference on Retroviruses and Opportunistic Infections in February, data were presented from the ongoing “DRIVE-FORWARD” phase 3 clinical trial evaluating the safety and efficacy of doravirine (MK-1439), an investigational non-nucleoside reverse transcriptase inhibitor for previously untreated adults with HIV-1 infection. The study met its primary efficacy endpoint, demonstrating the non-inferiority of once-daily doravirine to once-daily ritonavir-boosted darunavir.

 

·                  Positive results from a study of letermovir, an investigational antiviral medicine for the prevention of cytomegalovirus infection in high-risk bone marrow transplant patients, were presented at the BMT Tandem Meetings in February.

 

·                  Merck presented data from a trial for V212, an investigational inactivated varicella zoster virus vaccine for the prevention of herpes zoster or HZ, also known as shingles. The data demonstrated a reduction in the incidence of confirmed HZ cases by an estimated

 

Page 3



 

64 percent in immunocompromised patients and also were presented at the BMT Tandem Meetings.

 

First-Quarter Revenue Performance

 

The following table reflects sales of the company’s top pharmaceutical products, as well as total sales of Animal Health products.

 

 

 

First Quarter

 

$ in millions

 

2017

 

2016

 

Change

 

Change
Ex-Exchange

 

Total Sales

 

$9,434

 

$9,312

 

1

%

3

%

Pharmaceutical

 

8,185

 

8,104

 

1

%

2

%

JANUVIA / JANUMET

 

1,335

 

1,412

 

-5

%

-5

%

KEYTRUDA

 

584

 

249

 

134

%

137

%

ZETIA / VYTORIN

 

575

 

889

 

-35

%

-35

%

GARDASIL / GARDASIL 9

 

532

 

378

 

41

%

41

%

ZEPATIER

 

378

 

50

 

*

 

*

 

PROQUAD, M-M-R II and VARIVAX

 

355

 

357

 

0

%

1

%

ISENTRESS

 

305

 

340

 

-10

%

-10

%

REMICADE

 

229

 

349

 

-34

%

-31

%

ROTATEQ

 

224

 

188

 

19

%

19

%

Animal Health

 

939

 

829

 

13

%

14

%

Other Revenues

 

310

 

379

 

-18

%

-5

%

 

*Growth comparison not meaningful due to ongoing product launch.

 

Pharmaceutical Revenue

 

First-quarter pharmaceutical sales increased 1 percent to $8.2 billion, including a 1 percent negative impact from foreign exchange. The growth was driven by oncology, hepatitis C and vaccines, largely offset by the loss of market exclusivity for several products, as well as lower sales in the diabetes franchise.

 

Growth in oncology was due to higher sales of KEYTRUDA as the company continues to launch the product with new indications globally.

 

Growth in hepatitis C was driven by ZEPATIER (elbasvir and grazoprevir), a medicine for the treatment of chronic hepatitis C virus genotypes 1 or 4 infection, due to ongoing launches globally. Sales in the United States also reflect an approximately $40 million favorable adjustment to rebate accruals due to mix of business.

 

Growth in vaccines was primarily driven by higher sales of GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] and GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant), vaccines to prevent certain cancers and other diseases caused by HPV, in the United States reflecting the timing of public sector purchases, underlying demand and increased price, as well as higher sales of PNEUMOVAX 23

 

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(pneumococcal vaccine polyvalent) largely driven by demand in the United States. Growth in vaccines also reflects incremental sales of approximately $65 million, of which approximately $50 million relates to GARDASIL and GARDASIL 9, due to Merck now recording vaccine sales in the 19 European countries previously part of the Sanofi Pasteur MSD vaccines joint venture, which was terminated on Dec. 31, 2016.

 

Pharmaceutical sales reflect a decrease in the diabetes franchise of JANUVIA (sitagliptin) and JANUMET (sitagliptin and metformin HCl), medicines that help lower blood sugar in adults with type 2 diabetes, primarily due to the timing of customer purchases in the United States as anticipated for the quarter.

 

Sales growth also was offset by the loss of U.S. market exclusivity in 2016 for ZETIA (ezetimibe), a medicine for lowering LDL cholesterol; CUBICIN (daptomycin for injection), an I.V. antibiotic; and NASONEX (mometasone furoate monohydrate), an inhaled nasal corticosteroid for the treatment of nasal allergy symptoms; as well as by the ongoing impact of biosimilar competition in the company’s marketing territories in Europe for REMICADE (infliximab), a treatment for inflammatory diseases. In the aggregate, sales of these products declined $686 million during the first quarter of 2017 compared to the first quarter of 2016.

 

Animal Health Revenue

 

Animal Health sales totaled $939 million for the first quarter of 2017, an increase of 13 percent compared with the first quarter of 2016, including a 1 percent negative impact from foreign exchange. Growth was primarily due to sales increases in companion animal products, driven by the BRAVECTO (fluralaner) line of products that kill fleas and ticks in dogs and cats for up to 12 weeks, as well as in ruminants, poultry and swine products. In March, Animal Health completed the acquisition of Vallée S.A., a leading privately held producer of animal health products in Brazil.

 

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First-Quarter Expense, EPS and Related Information

 

The table below presents selected expense information.

 

$ in millions

 

GAAP

 

Acquisition- and
Divestiture-
Related Costs
3

 

Restructuring
Costs

 

Certain Other
Items

 

Non-GAAP1

 

First-Quarter 2017

 

 

 

 

 

 

 

 

 

 

 

Materials and production

 

$3,015

 

$855

 

$63

 

$—

 

$2,097

 

Marketing and administrative

 

2,411

 

20

 

1

 

 

2,390

 

Research and development

 

1,796

 

11

 

 

 

1,785

 

Restructuring costs

 

151

 

 

151

 

 

 

Other (income) expense, net

 

58

 

(3

)

 

(9

)

70

 

 

 

 

 

 

 

 

 

 

 

 

 

First-Quarter 2016

 

 

 

 

 

 

 

 

 

 

 

Materials and production

 

$3,572

 

$1,386

 

$47

 

$—

 

$2,139

 

Marketing and administrative

 

2,318

 

2

 

3

 

 

2,313

 

Research and development

 

1,659

 

35

 

55

 

 

1,569

 

Restructuring costs

 

91

 

 

91

 

 

 

Other (income) expense, net

 

48

 

 

 

 

48

 

 

GAAP Expense, EPS and Related Information

 

On a GAAP basis, the gross margin was 68.0 percent for the first quarter of 2017 compared to 61.6 percent for the first quarter of 2016. The increase in gross margin for the first quarter of 2017 was primarily driven by a lower net impact from acquisition- and divestiture-related costs and restructuring costs which reduced gross margin by 9.8 percentage points in the first quarter of 2017 as compared with 15.4 percentage points in the first quarter of 2016. The increase in gross margin also reflects the favorable effects of foreign exchange and lower inventory write-offs.

 

Marketing and administrative expenses were $2.4 billion in the first quarter of 2017, a 4 percent increase compared to the first quarter of 2016. The increase primarily reflects higher health care reform fee expenses, administrative costs, and promotion and direct selling expenses.

 

Research and development (R&D) expenses were $1.8 billion in the first quarter of 2017, an 8 percent increase compared to the first quarter of 2016. The increase reflects higher clinical development spending, partially offset by lower restructuring costs.

 

GAAP EPS was $0.56 for the first quarter of 2017 compared with $0.40 for the first quarter of 2016.

 


3  Includes expenses for the amortization of intangible assets and purchase accounting adjustments to inventories recognized as a result of acquisitions, intangible asset impairment charges and expense or income related to changes in the estimated fair value measurement of contingent consideration. Also includes integration, transaction and certain other costs related to business acquisitions and divestitures.

 

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Non-GAAP Expense, EPS and Related Information

 

The non-GAAP gross margin was 77.8 percent for the first quarter of 2017 compared to 77.0 percent for the first quarter of 2016. The increase in non-GAAP gross margin was largely driven by the favorable effects of foreign exchange and lower inventory write-offs.

 

Non-GAAP marketing and administrative expenses were $2.4 billion in the first quarter of 2017, an increase of 3 percent compared to the first quarter of 2016. The increase was driven primarily by higher health care reform fee expenses, administrative costs, and promotion and direct selling expenses.

 

Non-GAAP R&D expenses were $1.8 billion in the first quarter of 2017, a 14 percent increase compared to the first quarter of 2016. The increase primarily reflects higher clinical development spending.

 

Non-GAAP EPS was $0.88 for the first quarter of 2017 compared with $0.89 for the first quarter of 2016.

 

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

 

 

 

First Quarter

 

$ in millions, except EPS amounts

 

2017

 

2016

 

EPS

 

 

 

 

 

GAAP EPS

 

$0.56

 

$0.40

 

Difference4

 

0.32

 

0.49

 

Non-GAAP EPS that excludes items listed below1

 

$0.88

 

$0.89

 

 

 

 

 

 

 

Net Income

 

 

 

 

 

GAAP net income2

 

$1,551

 

$1,125

 

Difference

 

886

 

1,367

 

Non-GAAP net income that excludes items listed below1,2

 

$2,437

 

$2,492

 

 

 

 

 

 

 

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

 

 

 

 

 

Acquisition- and divestiture-related costs3

 

$883

 

$1,423

 

Restructuring costs

 

215

 

196

 

Other

 

(9

)

 

Net decrease (increase) in income before taxes

 

1,089

 

1,619

 

Estimated income tax (benefit) expense

 

(203

)

(252

)

Decrease (increase) in net income

 

$886

 

$1,367

 

 

Financial Outlook

 

Merck has narrowed and raised its full-year 2017 GAAP EPS range to be between $2.51 and $2.63. Merck has narrowed and raised its full-year 2017 non-GAAP EPS range to be between $3.76 and $3.88, including an approximately 1.5 percent negative impact from foreign exchange at mid-April 2017 exchange rates. The non-GAAP range excludes acquisition- and divestiture-related costs, costs related to restructuring programs and certain other items.

 


4  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.

 

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Merck has narrowed and raised its full-year 2017 revenue range to be between $39.1 billion and $40.3 billion, including an approximately 1.5 percent negative impact from foreign exchange at mid-April 2017 exchange rates.

 

The following table summarizes the company’s 2017 financial guidance.

 

 

 

GAAP

 

Non-GAAP1

 

 

 

 

 

 

 

Revenue

 

$39.1 to $40.3 billion

 

$39.1 to $40.3 billion**

 

Operating expenses

 

Lower than 2016

 

Higher than 2016 by a low-single digit rate

 

Effective tax rate

 

22.0% to 23.0%

 

21.0% to 22.0%

 

EPS

 

$2.51 to $2.63

 

$3.76 to $3.88

 

 

**The company does not have any non-GAAP adjustments to revenue.

 

A reconciliation of anticipated 2017 GAAP EPS to non-GAAP EPS and the items excluded from non-GAAP EPS are provided in the table below.

 

$ in millions, except EPS amounts

 

Full-Year 2017

 

 

 

 

 

GAAP EPS

 

$2.51 to $2.63

 

Difference4

 

1.25

 

Non-GAAP EPS that excludes items listed below1

 

$3.76 to $3.88

 

 

 

 

 

Acquisition- and divestiture-related costs

 

$3,600

 

Restructuring costs

 

600

 

Net decrease (increase) in income before taxes

 

4,200

 

Estimated income tax (benefit) expense

 

(750

)

Decrease (increase) in net income

 

$3,450

 

 

The expected full-year 2017 GAAP effective tax rate of 22.0 to 23.0 percent reflects an unfavorable impact of approximately 1 percentage point from the above items.

 

Total Employees

 

As of March 31, 2017, Merck had approximately 69,000 employees worldwide.

 

Earnings Conference Call

 

Investors, journalists and the general public may access a live audio webcast of the call today at 8:00 a.m. EDT on Merck’s website at http://investors.merck.com/events-and-presentations/default.aspx. Institutional investors and analysts can participate in the call by dialing (706) 758-9927 or (877) 381-5782 and using ID code number 91134398. Members of the media are invited to monitor the call by dialing (706) 758-9928 or (800) 399-7917 and using ID code number 91134398. Journalists who wish to ask questions are requested to contact a member of Merck’s Media Relations team at the conclusion of the call.

 

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About Merck

 

For more than a century, Merck, a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. 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. Today, Merck continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world - including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease and infectious diseases including HIV and Ebola. For more information, visit www.merck.com and connect with us on Twitter, Facebook, YouTube and LinkedIn. You can also follow our Twitter conversation at $MRK.

 

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

 

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) 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 the company’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; the company’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 the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

 

The company 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

 

Page 9



 

found in the company’s 2016 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

 

 

 

 

 

1Q17

 

1Q16

 

% Change

 

Sales

 

$

9,434

 

$

9,312

 

1

%

 

 

 

 

 

 

 

 

Costs, Expenses and Other

 

 

 

 

 

 

 

Materials and production (1)

 

3,015

 

3,572

 

-16

%

Marketing and administrative (1) 

 

2,411

 

2,318

 

4

%

Research and development (1) 

 

1,796

 

1,659

 

8

%

Restructuring costs (2) 

 

151

 

91

 

66

%

Other (income) expense, net (1)

 

58

 

48

 

21

%

Income Before Taxes

 

2,003

 

1,624

 

23

%

Taxes on Income

 

447

 

494

 

 

 

Net Income

 

1,556

 

1,130

 

38

%

Less: Net Income Attributable to Noncontrolling Interests

 

5

 

5

 

 

 

Net Income Attributable to Merck & Co., Inc.

 

$

1,551

 

$

1,125

 

38

%

Earnings per Common Share Assuming Dilution

 

$

0.56

 

$

0.40

 

40

%

 

 

 

 

 

 

 

 

Average Shares Outstanding Assuming Dilution

 

2,766

 

2,795

 

 

 

Tax Rate

 

22.3

%

30.4

%

 

 

 

(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.

 



 

MERCK & CO., INC.

GAAP TO NON-GAAP RECONCILIATION

FIRST QUARTER 2017

(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)

(UNAUDITED)

Table 2a

 

 

 

GAAP

 

Acquisition and
Divestiture-Related
Costs 
(1)

 

Restructuring
Costs 
(2)

 

Certain Other
Items

 

Adjustment
Subtotal

 

Non-GAAP

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Materials and production

 

$

3,015

 

855

 

63

 

 

 

918

 

$

2,097

 

Marketing and administrative

 

2,411

 

20

 

1

 

 

 

21

 

2,390

 

Research and development

 

1,796

 

11

 

 

 

 

 

11

 

1,785

 

Restructuring costs

 

151

 

 

 

151

 

 

 

151

 

 

Other (income) expense, net

 

58

 

(3

)

 

 

(9

)

(12

)

70

 

Income Before Taxes

 

2,003

 

(883

)

(215

)

9

 

(1,089

)

3,092

 

Income Tax Provision (Benefit)

 

447

 

(158

)(3)

(48

)(3)

3

(3)

(203

)

650

 

Net Income

 

1,556

 

(725

)

(167

)

6

 

(886

)

2,442

 

Net Income Attributable to Merck & Co., Inc.

 

1,551

 

(725

)

(167

)

6

 

(886

)

2,437

 

Earnings per Common Share Assuming Dilution

 

$

0.56

 

(0.26

)

(0.06

)

 

(0.32

)

$

0.88

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Tax Rate

 

22.3

%

 

 

 

 

 

 

 

 

21.0

%

 

Only the line items that are affected by non-GAAP adjustments are shown.

 

Merck is providing certain 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 results as it permits investors to understand how management assesses performance. Management uses these measures internally for planning and forecasting purposes and to measure the performance of the company along with other metrics. Senior management’s annual compensation is derived in part using non-GAAP income and non-GAAP EPS. This information should be considered in addition to, but not as a substitute for or superior to, information prepared in accordance with GAAP.

 

(1) Amounts included in materials and production costs primarily reflect $773 million of expenses for the amortization of intangible assets recognized as a result of acquisitions, as well as intangible asset impairment charges of $76 million.  Amounts included in marketing and administrative expenses reflect integration, transaction and certain other costs related to business acquisitions, including severance costs which are not part of the company’s formal restructuring programs, as well as transaction and certain other costs related to business divestitures.  Amounts included in research and development expenses primarily reflect changes in the estimated fair value measurement of liabilities for contingent consideration. 

 

(2) Amounts primarily include employee separation costs and accelerated depreciation associated with facilities to be closed or divested related to activities under the company’s formal restructuring programs.

 

(3) Represents the estimated tax impact on the reconciling items based on applying the statutory rate of the originating territory of the non-GAAP adjustments.

 



 

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

 

 

 

2017

 

2016

 

% Change

 

 

 

1Q

 

1Q

 

2Q

 

3Q

 

4Q

 

Full Year

 

1Q

 

TOTAL SALES (1)

 

$

9,434

 

$

9,312

 

$

9,844

 

$

10,536

 

$

10,115

 

$

39,807

 

1

 

PHARMACEUTICAL

 

8,185

 

8,104

 

8,700

 

9,443

 

8,904

 

35,151

 

1

 

Primary Care and Women’s Health

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cardiovascular

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Zetia

 

334

 

612

 

702

 

671

 

575

 

2,560

 

-46

 

Vytorin

 

241

 

277

 

293

 

273

 

299

 

1,141

 

-13

 

Liptruzet

 

49

 

23

 

33

 

39

 

50

 

146

 

114

 

Adempas

 

84

 

33

 

40

 

48

 

49

 

169

 

158

 

Diabetes

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Januvia

 

839

 

906

 

1,064

 

1,006

 

932

 

3,908

 

-7

 

Janumet

 

496

 

506

 

569

 

548

 

577

 

2,201

 

-2

 

General Medicine & Women’s Health

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Implanon / Nexplanon

 

170

 

134

 

164

 

148

 

160

 

606

 

27

 

NuvaRing

 

160

 

175

 

200

 

195

 

207

 

777

 

-9

 

Follistim AQ

 

81

 

94

 

73

 

101

 

87

 

355

 

-14

 

Hospital and Specialty

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Hepatitis

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Zepatier

 

378

 

50

 

112

 

164

 

229

 

555

 

*

 

HIV

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Isentress

 

305

 

340

 

338

 

372

 

337

 

1,387

 

-10

 

Hospital Acute Care

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Bridion

 

148

 

90

 

113

 

139

 

139

 

482

 

63

 

Noxafil

 

141

 

145

 

143

 

147

 

161

 

595

 

-3

 

Invanz

 

136

 

114

 

143

 

152

 

152

 

561

 

20

 

Cancidas

 

121

 

133

 

131

 

142

 

152

 

558

 

-9

 

Cubicin

 

96

 

292

 

357

 

320

 

119

 

1,087

 

-67

 

Primaxin

 

62

 

73

 

81

 

77

 

66

 

297

 

-15

 

Immunology

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Remicade

 

229

 

349

 

339

 

311

 

269

 

1,268

 

-34

 

Simponi

 

184

 

188

 

199

 

193

 

186

 

766

 

-2

 

Oncology

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Keytruda

 

584

 

249

 

314

 

356

 

483

 

1,402

 

134

 

Emend

 

133

 

126

 

143

 

137

 

144

 

549

 

6

 

Temodar

 

66

 

66

 

73

 

78

 

67

 

283

 

0

 

Diversified Brands

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Respiratory

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Singulair

 

186

 

237

 

229

 

239

 

210

 

915

 

-22

 

Nasonex

 

139

 

229

 

101

 

94

 

112

 

537

 

-40

 

Dulera

 

82

 

113

 

121

 

97

 

105

 

436

 

-27

 

Other

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cozaar / Hyzaar

 

112

 

126

 

132

 

131

 

121

 

511

 

-11

 

Arcoxia

 

103

 

111

 

117

 

114

 

108

 

450

 

-7

 

Fosamax

 

61

 

75

 

73

 

68

 

68

 

284

 

-19

 

Vaccines (2)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Gardasil / Gardasil 9

 

532

 

378

 

393

 

860

 

542

 

2,173

 

41

 

ProQuad / M-M-R II / Varivax

 

355

 

357

 

383

 

496

 

405

 

1,640

 

0

 

RotaTeq

 

224

 

188

 

130

 

171

 

162

 

652

 

19

 

Pneumovax 23

 

163

 

107

 

120

 

175

 

238

 

641

 

52

 

Zostavax

 

154

 

125

 

149

 

190

 

221

 

685

 

23

 

Other Pharmaceutical (3)

 

1,037

 

1,083

 

1,128

 

1,191

 

1,172

 

4,574

 

-4

 

ANIMAL HEALTH

 

939

 

829

 

900

 

865

 

884

 

3,478

 

13

 

Other Revenues (4)

 

310

 

379

 

244

 

228

 

327

 

1,178

 

-18

 

 

* 200% or greater

 

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

 

(1) Only select products are shown.

 

(2) Vaccine sales in 2017 include sales in the European markets that were previously part of the Sanofi Pasteur MSD (SPMSD) joint venture that was terminated on December 31, 2016. Amounts for 2016 include supply sales to SPMSD.

 

(3) Includes Pharmaceutical products not individually shown above. Other Vaccines sales included in Other Pharmaceutical were $88 million in the first quarter of 2017 and $103 million, $91 million, $135 million and $126 million for the first, second, third and fourth quarters of 2016, respectively.

 

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