EX-99.1 2 a18-5152_1ex99d1.htm EX-99.1

Exhibit 99.1

 

News Release

 

FOR IMMEDIATE RELEASE

 

Media Contacts:

Tracy Ogden

Investor Contacts:

Teri Loxam

 

(908) 740-1747

 

(908) 740-1986

 

 

 

 

 

Claire Gillespie

 

Amy Klug

 

(267) 305-0932

 

(908) 740-1898

 

Merck Announces Fourth-Quarter and Full-Year 2017 Financial Results

 

·            Fourth-Quarter 2017 Worldwide Sales Were $10.4 Billion, an Increase of 3 Percent, Including a 1 Percent Positive Impact from Foreign Exchange; Full-Year 2017 Worldwide Sales Were $40.1 Billion, an Increase of 1 Percent

 

·            Fourth-Quarter 2017 GAAP EPS Was $(0.32), Reflecting a $2.6 Billion Provisional Charge Related to U.S. Tax Legislation; Fourth-Quarter Non-GAAP EPS Was $0.98

 

·            Full-Year 2017 GAAP EPS Was $0.93, Reflecting a $2.6 Billion Provisional Charge Related to U.S. Tax Legislation and a $2.35 Billion Charge Related to the Formation of a Strategic Oncology Collaboration With AstraZeneca; Full-Year Non-GAAP EPS Was $3.98

 

·            2018 Financial Outlook

 

·                  Anticipates Full-Year 2018 Worldwide Sales to Be Between $41.2 Billion and $42.7 Billion, Including an Approximately 1 Percent Positive Impact from Foreign Exchange

 

·                  Expects Full-Year 2018 GAAP EPS to Be Between $2.97 and $3.12; Expects Non-GAAP EPS to Be Between $4.08 and $4.23, Including an Approximately 1 Percent Negative Impact from Foreign Exchange

 

·                  KEYTRUDA Significantly Improved Overall Survival and Progression-Free Survival as First-Line Treatment in Combination with Pemetrexed and Platinum Chemotherapy for Patients With Metastatic Non-squamous Non-Small Cell Lung Cancer in KEYNOTE-189 Study

 

KENILWORTH, N.J., Feb. 2, 2018 — Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the fourth quarter and full year of 2017.

 

“Our 2017 results reflect the underlying strength of our business and our ability to grow, despite significant headwinds,” said Kenneth C. Frazier, chairman and chief executive officer, Merck. “We enter 2018 with strong operating momentum, based on our key pillars of growth that will enable us to deliver on our mission of improving patients’ lives.”

 



 

Financial Summary

 

 

 

Fourth Quarter

 

Year Ended

 

$ in millions, except EPS amounts

 

2017

 

2016

 

Dec. 31,
2017

 

Dec. 31,
2016

 

Sales

 

$

10,433

 

$

10,115

 

$

40,122

 

$

39,807

 

GAAP net (loss) income1

 

(872

)

(594

)

2,568

 

3,920

 

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

 

2,665

 

2,470

 

10,933

 

10,538

 

GAAP EPS

 

(0.32

)

(0.22

)

0.93

 

1.41

 

Non-GAAP EPS that excludes certain items2*

 

0.98

 

0.89

 

3.98

 

3.78

 

 

*Refer to table on page 10.

 

Worldwide sales were $10.4 billion for the fourth quarter of 2017, an increase of 3 percent compared with the fourth quarter of 2016, including a 1 percent positive impact from foreign exchange. Full-year 2017 worldwide sales were $40.1 billion, an increase of 1 percent compared with the full year of 2016.

 

Sales in the fourth quarter and full year of 2017 reflect incremental sales of approximately $140 million and $400 million, respectively, due to the recording of vaccine sales from 19 European countries that were part of the Sanofi Pasteur MSD (SPMSD) vaccines joint venture, which was terminated on Dec. 31, 2016.

 

In addition, sales in the fourth quarter of 2017 include approximately $115 million for the partial replenishment of doses of GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant), a vaccine to prevent certain cancers and other diseases caused by HPV, that were borrowed from the U.S. Centers for Disease Control and Prevention (CDC) Pediatric Vaccine Stockpile in the third quarter. The effect of the borrowing and subsequent partial replenishment resulted in a net reduction in sales of $125 million for the full year of 2017.

 

Sales in the fourth quarter of 2017 compared with the fourth quarter of 2016 also reflect a favorable impact of approximately $150 million due to the timing of shipments in Japan in the prior year.

 

As expected, revenue in the fourth quarter and full year of 2017 was unfavorably affected by approximately $125 million and $260 million, respectively, from lost sales in certain markets related to the cyber-attack that occurred in June.

 

GAAP (generally accepted accounting principles) earnings (loss) per share assuming dilution (EPS) were $(0.32) for the fourth quarter and $0.93 for the full year of 2017, which reflect the impact of recently enacted U.S. tax legislation and for the full year also reflect a

 


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

2         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 and 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 Tables 2a and 2b attached to this release.

 

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charge related to the formation of a strategic oncology collaboration with AstraZeneca. Non-GAAP EPS of $0.98 for the fourth quarter and $3.98 for the full year of 2017 excludes acquisition- and divestiture-related costs, restructuring costs, a $2.6 billion provisional charge related to the U.S. tax legislation and certain other items. Non-GAAP EPS for the full year of 2017 also excludes a $2.35 billion aggregate charge related to the formation of the collaboration with AstraZeneca.

 

Pipeline Highlights

 

Merck expanded its focus in oncology by further advancing the development program for KEYTRUDA (pembrolizumab), an anti-PD-1 therapy, and Lynparza (olaparib), a PARP inhibitor co-developed and co-commercialized with AstraZeneca, and receiving key regulatory approvals.

 

·                  Merck announced the pivotal Phase 3 KEYNOTE-189 trial investigating KEYTRUDA in combination with pemetrexed (Alimta) and cisplatin or carboplatin, for the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), met its dual primary endpoints of overall survival (OS) and progression-free survival (PFS). Based on an interim analysis conducted by the independent Data Monitoring Committee, treatment with KEYTRUDA in combination with pemetrexed plus platinum chemotherapy resulted in significantly longer OS and PFS than pemetrexed plus platinum chemotherapy alone. Results from the trial will be presented at an upcoming medical meeting and submitted to regulatory authorities. KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is the first immuno-oncology combination to show improved OS for the first-line treatment of patients with metastatic non-squamous NSCLC.

 

·                  The Japanese Ministry of Health, Labour and Welfare approved KEYTRUDA for the treatment of patients with radically unresectable urothelial carcinoma who progressed after cancer chemotherapy.

 

·                  The company announced the pivotal Phase 3 KEYNOTE-061 trial investigating KEYTRUDA as a second-line treatment for patients with advanced gastric or gastroesophageal junction adenocarcinoma did not meet its primary endpoint of overall survival in patients whose tumors expressed PD-L1.

 

·                  The company and The European Organisation for Research and Treatment of Cancer (EORTC) announced the Phase 3 EORTC1325/KEYNOTE-054 trial investigating KEYTRUDA as monotherapy for surgically resected high-risk melanoma met the primary endpoint of recurrence-free survival and, based on an interim analysis and following review by the Independent Data Monitoring Committee, resulted in significantly longer recurrence-free survival than placebo.

 

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·                  The U.S. Food and Drug Administration (FDA) accepted for review the supplemental Biologics License Application (sBLA) for KEYTRUDA for the treatment of adult and pediatric patients with refractory primary mediastinal B-cell lymphoma, or who have relapsed after two or more prior lines of therapy. The FDA granted Priority Review status with a PDUFA date of April 3, 2018, and previously granted Breakthrough Therapy Designation to KEYTRUDA in January 2017 for this indication.

 

·                  The FDA granted Breakthrough Therapy Designation for KEYTRUDA in combination with Eisai’s multiple receptor tyrosine kinase inhibitor Lenvima (lenvatinib) for the potential treatment of patients with advanced and/or metastatic renal cell carcinoma, which is being jointly developed as part of a collaboration between Merck and Esai. This marks the 12th Breakthrough Therapy Designation granted to KEYTRUDA.

 

·                  The FDA approved Lynparza for use in patients with germline BRCA-mutated, HER2-negative metastatic breast cancer who have been previously treated with chemotherapy either in the neoadjuvant, adjuvant or metastatic settings. Lynparza is the first PARP inhibitor approved for breast cancer. A supplemental New Drug Application (NDA) was submitted to Japan’s Pharmaceuticals and Medical Devices Agency for the same use.

 

·                  The Japanese Ministry of Health, Labour and Welfare approved Lynparza for use as a maintenance therapy for patients with platinum-sensitive relapsed ovarian cancer, regardless of their BRCA mutation status, who responded to their last platinum-based chemotherapy. Lynparza is the first PARP inhibitor approved in Japan.

 

Merck and Pfizer announced that the FDA approved STEGLATRO (ertugliflozin) tablets, an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor, the fixed-dose combination STEGLUJAN (ertugliflozin and sitagliptin) and the fixed-dose combination SEGLUROMET (ertugliflozin and metformin hydrochloride) to help improve glycemic control in adults with type 2 diabetes. Additionally, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion for these medicines.

 

The FDA and European Commission approved PREVYMIS (letermovir), once-daily tablets for oral use and injection for intravenous infusion, indicated for prevention of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant.

 

The FDA accepted for review two NDAs for doravirine, the company’s investigational non-nucleoside reverse transcriptase inhibitor, for the treatment of HIV-1 infection in adults. The NDAs include data for doravirine as a once-daily tablet for use in combination with other antiretroviral agents and for use of doravirine with lamivudine and tenofovir disoproxil fumarate

 

Page 4



 

in a once-daily fixed-dose combination single tablet as a complete regimen. The PDUFA date for both applications is Oct. 23, 2018.

 

The FDA approved ISENTRESS (raltegravir), the company’s integrase inhibitor, for use in combination with other antiretroviral agents for the treatment of HIV-1 in newborn patients from birth to four weeks of age weighing at least 2 kg.

 

Fourth-Quarter and Full-Year Revenue Performance

 

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

 

 

 

Fourth Quarter

 

Year Ended

 

$ in millions

 

2017

 

2016

 

Change

 

Change Ex-Exchange

 

Dec. 31,
2017

 

Dec. 31,
2016

 

Change

 

Change Ex-Exchange

 

Total Sales

 

$

10,433

 

$

10,115

 

3

%

2

%

$

40,122

 

$

39,807

 

1

%

1

%

Pharmaceutical

 

9,290

 

8,904

 

4

%

3

%

35,390

 

35,151

 

1

%

1

%

JANUVIA / JANUMET

 

1,524

 

1,509

 

1

%

0

%

5,896

 

6,109

 

-3

%

-4

%

KEYTRUDA

 

1,297

 

483

 

169

%

166

%

3,809

 

1,402

 

172

%

171

%

GARDASIL / GARDASIL 9

 

633

 

542

 

17

%

15

%

2,308

 

2,173

 

6

%

6

%

ZETIA / VYTORIN

 

509

 

873

 

-42

%

-44

%

2,095

 

3,701

 

-43

%

-44

%

PROQUAD, M-M-R II and VARIVAX

 

403

 

405

 

0

%

-1

%

1,676

 

1,640

 

2

%

2

%

ISENTRESS / ISENTRESS HD

 

308

 

337

 

-9

%

-11

%

1,204

 

1,387

 

-13

%

-14

%

ZEPATIER

 

296

 

229

 

29

%

27

%

1,660

 

555

 

199

%

199

%

PNEUMOVAX 23

 

263

 

238

 

11

%

11

%

821

 

641

 

28

%

29

%

SIMPONI

 

217

 

186

 

17

%

10

%

819

 

766

 

7

%

6

%

BRIDION

 

209

 

139

 

50

%

49

%

704

 

482

 

46

%

46

%

Animal Health

 

981

 

884

 

11

%

8

%

3,875

 

3,478

 

11

%

11

%

Other Revenues

 

162

 

327

 

-51

%

-27

%

857

 

1,178

 

-27

%

-13

%

 

Pharmaceutical Revenue

 

Fourth-quarter pharmaceutical sales increased 4 percent to $9.3 billion, including a 1 percent positive impact from foreign exchange. The increase was driven primarily by significant growth of KEYTRUDA, reflecting the company’s continued launches with new indications globally. Strong momentum for the treatment of patients with NSCLC contributed significantly to KEYTRUDA’s overall growth, as it is the only anti-PD-1 approved in the first-line setting.

 

Sales of GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] and GARDASIL 9, vaccines to prevent certain cancers and other diseases caused by HPV, increased in the fourth quarter driven primarily by the commercial launch in China and growth in Europe due to the termination of the SPMSD joint venture noted above, partially offset by lower sales in the United States. The decline in U.S. sales reflects the timing of public sector purchasing that was largely offset by the partial replenishment of borrowed doses into the CDC stockpile noted above.

 

Page 5



 

The ongoing launch of BRIDION (sugammadex) Injection 100 mg/mL, a medicine for the reversal of neuromuscular blockade induced by rocuronium bromide or vecuronium bromide in adults undergoing surgery, also contributed to growth in the quarter driven by strong global demand.

 

Pharmaceutical sales also reflect higher sales of ZEPATIER (elbasvir and grazoprevir), a medicine for the treatment of chronic hepatitis C virus genotypes 1 or 4 infection, due to ongoing launches across Europe and Asia Pacific. The company anticipates that future sales of ZEPATIER will be unfavorably affected by increasing competition and declining patient volumes.

 

Performance of JANUVIA (sitagliptin) and JANUMET (sitagliptin and metformin HCI), medicines that help lower blood sugar in adults with type 2 diabetes, reflects pricing pressure offset by continued volume growth globally.

 

Sales growth for the quarter was partially offset by impacts from the loss of U.S. market exclusivity for ZETIA (ezetimibe) in late 2016 and VYTORIN (ezetimibe/simvastatin) in April 2017, medicines for lowering LDL cholesterol; biosimilar competition for REMICADE (infliximab), a treatment for inflammatory diseases, in the company’s marketing territories in Europe; and the 2017 loss of exclusivity for CANCIDAS (caspofungin acetate for injection), an antifungal, in Europe. In the aggregate, sales of these products declined approximately $500 million during the fourth quarter of 2017 compared to the fourth quarter of 2016.

 

Sales of ZOSTAVAX (zoster vaccine live), a vaccine for the prevention of herpes zoster, declined significantly in the quarter, primarily due to the approval of a competitor product that received a preferential recommendation from the U.S. Advisory Committee on Immunization Practices on Oct. 25, 2017. The company anticipates that future sales of ZOSTAVAX will be unfavorably affected by this competition.

 

Full-year 2017 pharmaceutical sales increased 1 percent to $35.4 billion. Growth was driven by the ongoing global launches of KEYTRUDA, ZEPATIER and BRIDION. In the aggregate, sales of these products increased $3.7 billion in 2017 compared to 2016. These increases were mostly offset by sales declines of the products affected by loss of exclusivity as described above for the quarter, as well as CUBICIN (daptomycin for injection), an I.V. antibiotic, SINGULAIR (montelukast sodium), a once-a-day oral medicine for the chronic treatment of asthma and the relief of symptoms of allergic rhinitis, NASONEX (mometasone furoate monohydrate), an inhaled nasal corticosteroid for the treatment of nasal allergy symptoms, and other products which together totaled $3.3 billion. Additionally, sales growth was offset by declines in the diabetes franchise due to pricing pressure partially offset by continued volume growth globally.

 

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Animal Health Revenue

 

Animal Health sales totaled $981 million for the fourth quarter of 2017, an increase of 11 percent compared with the fourth quarter of 2016, including a 3 percent positive impact from foreign exchange. Worldwide sales for the full year of 2017 were $3.9 billion, also an increase of 11 percent. Growth in both periods was driven by sales increases in companion animal products, primarily the BRAVECTO (fluralaner) line of products that kill fleas and ticks in dogs and cats for up to 12 weeks, and companion animal vaccines. Additionally, higher sales of ruminants products, swine products and poultry products all contributed to growth.

 

Fourth-Quarter and Full-Year Expense, EPS and Related Information

 

The tables below present selected expense information.

 

$ in millions

 

GAAP

 

Acquisition- and
Divestiture-
Related Costs
3

 

Restructuring
Costs

 

Certain Other
Items

 

Non-GAAP2

 

Fourth-Quarter 2017

 

 

 

 

 

 

 

 

 

 

 

Materials and production

 

$

3,406

 

$

737

 

$

17

 

$

 

$

2,652

 

Marketing and administrative

 

2,580

 

4

 

(1

)

 

2,577

 

Research and development

 

2,055

 

(5

)

 

 

2,060

 

Restructuring costs

 

306

 

 

306

 

 

 

Other (income) expense, net

 

(19

)

1

 

 

(7

)

(13

)

 

 

 

 

 

 

 

 

 

 

 

 

Fourth-Quarter 2016

 

 

 

 

 

 

 

 

 

 

 

Materials and production

 

$

3,332

 

$

756

 

$

32

 

$

 

$

2,544

 

Marketing and administrative

 

2,593

 

22

 

4

 

 

2,567

 

Research and development

 

4,650

 

2,897

 

9

 

 

1,744

 

Restructuring costs

 

265

 

 

265

 

 

 

Other (income) expense, net

 

631

 

35

 

 

564

 

32

 

 

$ in millions

 

GAAP

 

Acquisition- and
Divestiture-
Related Costs
3

 

Restructuring
Costs

 

Certain Other
Items

 

Non-GAAP2

 

Year Ended Dec. 31, 2017

 

 

 

 

 

 

 

 

 

 

 

Materials and production

 

$

12,775

 

$

3,187

 

$

138

 

$

 

$

9,450

 

Marketing and administrative

 

9,830

 

44

 

2

 

 

9,784

 

Research and development

 

9,982

 

284

 

11

 

2,350

 

7,337

 

Restructuring costs

 

776

 

 

776

 

 

 

Other (income) expense, net

 

12

 

19

 

 

(16

)

9

 

 

 

 

 

 

 

 

 

 

 

 

 

Year Ended Dec. 31, 2016

 

 

 

 

 

 

 

 

 

 

 

Materials and production

 

$

13,891

 

$

4,035

 

$

181

 

$

 

$

9,675

 

Marketing and administrative

 

9,762

 

78

 

95

 

 

9,589

 

Research and development

 

10,124

 

3,152

 

142

 

 

6,830

 

Restructuring costs

 

651

 

 

651

 

 

 

Other (income) expense, net

 

720

 

47

 

 

558

 

115

 

 


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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GAAP Expense, EPS and Related Information

 

Gross margin was 67.4 percent for the fourth quarter of 2017 compared to 67.1 percent for the fourth quarter of 2016. The gross margin was 68.2 percent for the full year of 2017 compared to 65.1 percent for the full year of 2016. The increase in gross margin for the full year of 2017 was primarily driven by lower acquisition- and divestiture-related costs and restructuring costs which negatively affected gross margin by 8.2 percentage points in the full year of 2017 compared with 10.6 percentage points for the full year of 2016. In addition, gross margin was impacted by the favorable effects of product mix partially offset by costs related to the cyber-attack.

 

Marketing and administrative expenses were $2.6 billion in the fourth quarter of 2017, a 1 percent decrease compared to the fourth quarter of 2016. The decrease primarily reflects lower acquisition- and divestiture-related costs. Full-year 2017 marketing and administrative expenses were $9.8 billion, a 1 percent increase compared to the full year of 2016. The increase reflects higher administrative costs, including costs associated with the company now operating its European vaccines business in the countries that were previously part of the SPMSD vaccines joint venture, remediation costs related to the cyber-attack and higher promotion expenses related to product launches, partially offset by lower restructuring costs and acquisition- and divestiture-related costs.

 

Research and development (R&D) expenses were $2.1 billion in the fourth quarter of 2017 compared with $4.7 billion in the fourth quarter of 2016. The decline was driven primarily by lower in-process research and development (IPR&D) impairment charges, partially offset by higher expenses related to business development transactions, clinical development spending and investment in early drug development. R&D expenses were $10.0 billion for the full year of 2017, a 1 percent decrease compared to the full year of 2016. The decline reflects lower IPR&D impairment charges and restructuring costs. These were offset by a $2.35 billion aggregate charge recorded in 2017 related to the formation of the collaboration with AstraZeneca, as well as a reduction in prior year expenses related to a decrease in the estimated fair value measurement of liabilities for contingent consideration and higher clinical development spending.

 

Other (income) expense, net, was $19 million of income in the fourth quarter of 2017 compared to $631 million of expense in the fourth quarter of 2016 and was $12 million of expense for the full year of 2017 compared to $720 million of expense for the full year of 2016. Other (income) expense, net, in 2017 reflects the favorable impacts of foreign exchange and gains on sales of securities, partially offset by a loss on the extinguishment of debt. Other (income) expense, net, for the fourth quarter and full year of 2016 includes a $625 million charge to settle worldwide KEYTRUDA patent litigation.

 

Page 8



 

The effective income tax rates of 141.0 percent for the fourth quarter and 61.6 percent for full year of 2017 include the unfavorable impact of a $2.6 billion provisional charge related to U.S. tax legislation. The provisional tax charge includes a one-time repatriation transition tax of approximately $5.0 billion, which will be paid over eight years. The transition tax was partially offset by adjustments to deferred tax liabilities, including taxes previously provided on foreign earnings and remeasurement of net U.S. deferred tax liabilities. The provisional tax charge may change in 2018 based on further analysis and regulatory guidance. In addition, the effective income tax rate for the full year of 2017 reflects the unfavorable impact of a $2.35 billion aggregate charge related to the formation of the collaboration with AstraZeneca for which no tax benefit has been recognized, partially offset by the favorable impact of a net tax benefit of $234 million related to the settlement of certain federal income tax issues.

 

GAAP EPS was $(0.32) for the fourth quarter of 2017 compared with $(0.22) for the fourth quarter of 2016. GAAP EPS was $0.93 for the full year of 2017 compared with $1.41 for the full year of 2016.

 

Non-GAAP Expense, EPS and Related Information

 

The non-GAAP gross margin was 74.6 percent for the fourth quarter of 2017, compared to 74.8 percent for the fourth quarter of 2016. The non-GAAP gross margin was 76.4 percent for the full year of 2017 compared to 75.7 percent for the full year of 2016. The increase in non-GAAP gross margin for the full year of 2017 reflects the favorable effects of product mix partially offset by costs related to the cyber-attack.

 

Non-GAAP marketing and administrative expenses were $2.6 billion in the fourth quarter of 2017, comparable to the fourth quarter of 2016. Non-GAAP marketing and administrative expenses were $9.8 billion for the full year of 2017, a 2 percent increase compared to the full year of 2016. The increase reflects higher administrative costs, including costs associated with the company now operating its European vaccines business in the countries that were previously part of the SPMSD vaccines joint venture, higher promotion costs related to product launches and remediation costs related to the cyber-attack.

 

Non-GAAP R&D expenses were $2.1 billion in the fourth quarter of 2017, an 18 percent increase compared to the fourth quarter of 2016. The increase reflects higher expenses related to business development transactions, clinical development spending and investment in early drug development. Non-GAAP R&D expenses were $7.3 billion for the full year of 2017, a 7 percent increase compared to the full year of 2016, reflecting increased clinical development spending.

 

Non-GAAP other (income) expense, net, was $13 million of income in the fourth quarter of 2017 compared to $32 million of expense in the fourth quarter of 2016. Non-GAAP other

 

Page 9



 

(income) expense, net, for the full year of 2017 was $9 million of expense compared to $115 million of expense for the full year of 2016. Non-GAAP other (income) expense, net, in 2017 reflects the favorable impact of foreign exchange and realized gains on sales of equity securities, partially offset by a loss on extinguishment of debt.

 

The non-GAAP effective income tax rate for the fourth quarter of 2017 was 15.3 percent compared with 23.3 percent for the fourth quarter of 2016 and was 19.1 percent for the full year of 2017 compared with 22.3 percent for the full year of 2016.

 

Non-GAAP EPS was $0.98 for the fourth quarter of 2017 compared with $0.89 for the fourth quarter of 2016. Non-GAAP EPS was $3.98 for the full year of 2017 compared with $3.78 for the full year of 2016.

 

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

 

 

 

Fourth Quarter

 

Year Ended

 

$ in millions, except EPS amounts

 

2017

 

2016

 

Dec. 31,
2017

 

Dec. 31,
2016

 

EPS

 

 

 

 

 

 

 

 

 

GAAP EPS

 

$

(0.32

)

$

(0.22

)

$

0.93

 

$

1.41

 

Difference4

 

1.30

 

1.11

 

3.05

 

2.37

 

Non-GAAP EPS that excludes items listed below2

 

$

0.98

 

$

0.89

 

$

3.98

 

$

3.78

 

 

 

 

 

 

 

 

 

 

 

Net Income

 

 

 

 

 

 

 

 

 

GAAP net (loss) income1

 

$

(872

)

$

(594

)

$

2,568

 

$

3,920

 

Difference

 

3,537

 

3,064

 

8,365

 

6,618

 

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

 

$

2,665

 

$

2,470

 

$

10,933

 

$

10,538

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

 

 

Acquisition- and divestiture-related costs3

 

$

737

 

$

3,710

 

$

3,534

 

$

7,312

 

Restructuring costs

 

322

 

310

 

927

 

1,069

 

Aggregate charge related to the formation of a collaboration with AstraZeneca

 

 

 

2,350

 

 

Charge to settle worldwide KEYTRUDA patent litigation

 

 

625

 

 

625

 

Other

 

(7

)

(61

)

(16

)

(67

)

Net decrease (increase) in income before taxes

 

1,052

 

4,584

 

6,795

 

8,939

 

Income tax (benefit) expense5

 

2,485

 

(1,520

)

1,570

 

(2,321

)

Decrease (increase) in net income

 

$

3,537

 

$

3,064

 

$

8,365

 

$

6,618

 

 

Financial Outlook

 

At mid-January 2018 exchange rates, Merck anticipates full-year 2018 revenue to be between $41.2 billion and $42.7 billion, including an approximately 1 percent positive impact from foreign exchange.

 


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.

5              Includes the estimated tax impact on the reconciling items. In addition, amounts for fourth-quarter and full-year 2017 include a $2.6 billion provisional charge related to U.S. tax legislation. Amount for full year 2017 also includes a $234 million net benefit related to the settlement of certain federal income tax issues, as well as a benefit of $88 million related to the settlement of a state income tax issue.

 

Page 10



 

Merck expects its full-year 2018 GAAP EPS to be between $2.97 and $3.12. Merck expects its full-year 2018 non-GAAP EPS to be between $4.08 and $4.23, including an approximately 1 percent negative impact from foreign exchange. The non-GAAP range excludes acquisition- and divestiture-related costs and costs related to restructuring programs.

 

The following table summarizes the company’s full year 2018 financial guidance.

 

 

 

GAAP

 

Non-GAAP2

 

 

 

 

 

 

 

Revenue

 

$41.2 to $42.7 billion

 

$41.2 to $42.7 billion**

 

Operating expenses

 

Lower than 2017 by a high-single digit rate

 

Higher than 2017 by a low- to mid-single digit rate

 

Effective tax rate

 

19.0% to 20.0%

 

19.0% to 20.0%

 

EPS

 

$2.97 to $3.12

 

$4.08 to $4.23

 

 

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

 

The guidance for both GAAP and non-GAAP operating expenses reflects the adoption of new accounting guidance on Jan. 1, 2018, related to defined benefit plans that requires a retroactive reclassification of certain components of net benefit cost/credit within the consolidated statement of income. There is no impact to net income as a result of adopting the new guidance. See supplemental information on the Investors section of Merck’s website (http://investors.merck.com) for additional details on the 2017 reclassification.

 

A reconciliation of anticipated 2018 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 2018

 

 

 

 

 

GAAP EPS

 

$2.97 to $3.12

 

Difference4

 

1.11

 

Non-GAAP EPS that excludes items listed below2

 

$4.08 to $4.23

 

 

 

 

 

Acquisition- and divestiture-related costs

 

$3,200

 

Restructuring costs

 

500

 

Net decrease (increase) in income before taxes

 

3,700

 

Estimated income tax (benefit) expense

 

(715

)

Decrease (increase) in net income

 

$2,985

 

 

Capital Allocation

 

The recently enacted U.S. tax legislation improves Merck’s financial flexibility to invest in sustainable long-term value creating opportunities. In addition to the company’s ongoing investment in R&D, business development and continued support of the dividend, as well as share repurchases, the company also:

 

·                  Plans to invest approximately $12 billion over 5 years in capital projects including approximately $8 billion in the United States

·                  Made a contribution to the Merck Foundation in the fourth quarter of 2017

·                  Plans to provide a one-time, long-term incentive award for its eligible non-executive employees in the second quarter of 2018

 

Page 11



 

Total Employees

 

As of Dec. 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. EST 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 9899537. Members of the media are invited to monitor the call by dialing (706) 758-9928 or (800) 399-7917 and using ID code number 9899537. 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

 

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.

 

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

 

Page 12



 

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 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 13



 

MERCK & CO., INC.

CONSOLIDATED STATEMENT OF INCOME - GAAP

(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)

(UNAUDITED)

Table 1

 

 

 

GAAP

 

 

 

GAAP

 

 

 

 

 

4Q17

 

4Q16

 

% Change

 

Full Year
2017

 

Full Year
2016

 

% Change

 

Sales

 

$

10,433

 

$

10,115

 

3

%

$

40,122

 

$

39,807

 

1

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Costs, Expenses and Other

 

 

 

 

 

 

 

 

 

 

 

 

 

Materials and production (1)

 

3,406

 

3,332

 

2

%

12,775

 

13,891

 

-8

%

Marketing and administrative (1) 

 

2,580

 

2,593

 

-1

%

9,830

 

9,762

 

1

%

Research and development (1) (2)

 

2,055

 

4,650

 

-56

%

9,982

 

10,124

 

-1

%

Restructuring costs (3) 

 

306

 

265

 

15

%

776

 

651

 

19

%

Other (income) expense, net (1) (4)

 

(19

)

631

 

*

 

12

 

720

 

-98

%

Income (Loss) Before Taxes

 

2,105

 

(1,356

)

*

 

6,747

 

4,659

 

45

%

Income Tax Provision (Benefit) (1)

 

2,969

 

(769

)

 

 

4,155

 

718

 

 

 

Net (Loss) Income

 

(864

)

(587

)

47

%

2,592

 

3,941

 

-34

%

Less: Net Income Attributable to Noncontrolling Interests

 

8

 

7

 

 

 

24

 

21

 

 

 

Net (Loss) Income Attributable to Merck & Co., Inc.

 

$

(872

)

$

(594

)

47

%

$

2,568

 

$

3,920

 

-34

%

(Loss) Earnings per Common Share Assuming Dilution (5)

 

$

(0.32

)

$

(0.22

)

45

%

$

0.93

 

$

1.41

 

-34

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Average Shares Outstanding Assuming Dilution (5)

 

2,715

 

2,755

 

 

 

2,748

 

2,787

 

 

 

Tax Rate (6)

 

141.0

%

56.7

%

 

 

61.6

%

15.4

%

 

 

 

* 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) Research and development expenses for full year 2017 include a $2.35 billion aggregate charge recorded in conjunction with the formation of a collaboration with AstraZeneca.

 

(3) Represents separation and other related costs associated with restructuring activities under the company’s formal restructuring programs.

 

(4) Other (income) expense, net in the fourth quarter and full year of 2016 includes a $625 million charge to settle worldwide patent litigation related to KEYTRUDA.

 

(5) Because the company recorded a net loss in the fourth quarter of 2017 and 2016, no potential dilutive common shares were used in the computation of loss per common share assuming dilution as the effect would have been anti-dilutive.

 

(6) The effective income tax rates for the fourth quarter and full year of 2017 reflect the net unfavorable impact of a $2.6 billion provisional charge related to the enactment of U.S. tax legislation.  The effective income tax rate for the full year of 2017 also reflects the unfavorable impact of a $2.35 billion aggregate pretax charge recorded in conjunction with the formation of a collaboration with AstraZeneca for which no tax benefit has been recognized.  Additionally, the effective income tax rate for the full year of 2017 reflects the favorable impact of a net tax benefit of $234 million related to the settlement of certain federal income tax issues.

 



 

MERCK & CO., INC.

GAAP TO NON-GAAP RECONCILIATION

FOURTH 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

 

$

3,406

 

737

 

17

 

 

 

754

 

$

2,652

 

Marketing and administrative

 

2,580

 

4

 

(1

)

 

 

3

 

2,577

 

Research and development

 

2,055

 

(5

)

 

 

 

(5

)

2,060

 

Restructuring costs

 

306

 

 

 

306

 

 

 

306

 

 

Other (income) expense, net

 

(19

)

1

 

 

 

(7

)

(6

)

(13

)

Income Before Taxes

 

2,105

 

(737

)

(322

)

7

 

(1,052

)

3,157

 

Income Tax Provision (Benefit)

 

2,969

 

(88

)(3)

(50

)(3)

2,623

(4)

2,485

 

484

 

Net (Loss) Income

 

(864

)

(649

)

(272

)

(2,616

)

(3,537

)

2,673

 

Net (Loss) Income Attributable to Merck & Co., Inc.

 

(872

)

(649

)

(272

)

(2,616

)

(3,537

)

2,665

 

(Loss) Earnings per Common Share Assuming Dilution

 

$

(0.32

)

(0.24

)

(0.10

)

(0.96

)

(1.30

)

$

0.98

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Tax Rate

 

141.0

%

 

 

 

 

 

 

 

 

15.3

%

 

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 expenses for the amortization of intangible assets recognized as a result of business acquisitions.  Amounts included in marketing and administrative expenses reflect integration, transaction and certain other costs related to business acquisitions and divestitures.  Amounts included in research and development expenses primarily reflect a reduction of expenses related to a decrease in the estimated fair value measurement of liabilities for contingent consideration.  Amounts included in other (income) expense, net reflect goodwill and intangible asset impairment charges related to a business in the Healthcare Services segment, largely offset by royalty income in connection with the termination of the Sanofi-Pasteur MSD joint venture.

 

(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.

 

(4) Includes the estimated tax impact on the reconciling items based on applying the statutory rate of the originating territory of the non-GAAP adjustments, as well as a $2.6 billion provisional charge related to the enactment of U.S. tax legislation.

 



 

MERCK & CO., INC.

GAAP TO NON-GAAP RECONCILIATION

FULL YEAR 2017

(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)

(UNAUDITED)

Table 2b

 

 

 

GAAP

 

Acquisition and
Divestiture-Related
Costs 
(1)

 

Restructuring
Costs 
(2)

 

Certain Other
Items 
(3)

 

Adjustment
Subtotal

 

Non-GAAP

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Materials and production

 

$

12,775

 

3,187

 

138

 

 

 

3,325

 

$

9,450

 

Marketing and administrative

 

9,830

 

44

 

2

 

 

 

46

 

9,784

 

Research and development

 

9,982

 

284

 

11

 

2,350

 

2,645

 

7,337

 

Restructuring costs

 

776

 

 

 

776

 

 

 

776

 

 

Other (income) expense, net

 

12

 

19

 

 

 

(16

)

3

 

9

 

Income Before Taxes

 

6,747

 

(3,534

)

(927

)

(2,334

)

(6,795

)

13,542

 

Income Tax Provision (Benefit)

 

4,155

 

(552

)(4)

(182

)(4)

2,304

(5)

1,570

 

2,585

 

Net Income

 

2,592

 

(2,982

)

(745

)

(4,638

)

(8,365

)

10,957

 

Net Income Attributable to Merck & Co., Inc.

 

2,568

 

(2,982

)

(745

)

(4,638

)

(8,365

)

10,933

 

Earnings per Common Share Assuming Dilution

 

$

0.93

 

(1.09

)

(0.27

)

(1.69

)

(3.05

)

$

3.98

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Tax Rate

 

61.6

%

 

 

 

 

 

 

 

 

19.1

%

 

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 $3.1 billion of expenses for the amortization of intangible assets recognized as a result of business acquisitions, as well as $134 million of intangible asset impairment charges.  Amounts included in marketing and administrative expenses reflect integration, transaction and certain other costs related to business acquisitions and divestitures.  Amounts included in research and development expenses reflect $257 million of in-process research and development (IPR&D) impairment charges and $27 million of expenses related to an increase in the estimated fair value measurement of liabilities for contingent consideration.  Amounts included in other (income) expense, net reflect goodwill and intangible asset impairment charges related to a business in the Healthcare Services segment, as well as expenses related to changes in the estimated fair value measurement of liabilities for contingent consideration, partially offset by royalty income in connection with the termination of the Sanofi-Pasteur MSD joint venture.

 

(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) Amount included in research and development expenses represents an aggregate charge recorded in conjunction with the formation of a collaboration with AstraZeneca.

 

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

 

(5) Includes the estimated tax impact on the reconciling items based on applying the statutory rate of the originating territory of the non-GAAP adjustments. Also includes a $2.6 billion provisional charge related to the enactment of U.S. tax legislation, as well as a $234 million net tax benefit related to the settlement of certain federal income tax issues and an $88 million tax benefit related to the settlement of a state income tax issue.

 



 

MERCK & CO., INC.
FRANCHISE / KEY PRODUCT SALES

(AMOUNTS IN MILLIONS)
Table 3

 

 

 

2017

 

2016

 

4Q

 

Full Year

 

 

 

1Q

 

2Q

 

3Q

 

4Q

 

Full Year

 

1Q

 

2Q

 

3Q

 

4Q

 

Full Year

 

Nom % 

 

Ex-Exch %

 

Nom % 

 

Ex-Exch %

 

TOTAL SALES (1)

 

$

9,434

 

$

9,930

 

$

10,325

 

$

10,433

 

$

40,122

 

$

9,312

 

$

9,844

 

$

10,536

 

$

10,115

 

$

39,807

 

3

 

2

 

1

 

1

 

PHARMACEUTICAL

 

8,185

 

8,759

 

9,156

 

9,290

 

35,390

 

8,104

 

8,700

 

9,443

 

8,904

 

35,151

 

4

 

3

 

1

 

1

 

Primary Care and Women’s Health

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cardiovascular

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Zetia

 

334

 

367

 

320

 

323

 

1,344

 

612

 

702

 

671

 

575

 

2,560

 

-44

 

-45

 

-48

 

-47

 

Vytorin

 

241

 

182

 

142

 

186

 

751

 

277

 

293

 

273

 

299

 

1,141

 

-38

 

-41

 

-34

 

-35

 

Atozet

 

49

 

63

 

59

 

54

 

225

 

23

 

33

 

39

 

50

 

146

 

7

 

2

 

54

 

51

 

Adempas

 

84

 

67

 

70

 

79

 

300

 

33

 

40

 

48

 

49

 

169

 

63

 

60

 

78

 

77

 

Diabetes

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Januvia

 

839

 

948

 

1,012

 

938

 

3,737

 

906

 

1,064

 

1,006

 

932

 

3,908

 

1

 

1

 

-4

 

-4

 

Janumet

 

496

 

563

 

513

 

586

 

2,158

 

506

 

569

 

548

 

577

 

2,201

 

2

 

-1

 

-2

 

-3

 

General Medicine & Women’s Health

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NuvaRing

 

160

 

199

 

214

 

188

 

761

 

175

 

200

 

195

 

207

 

777

 

-9

 

-10

 

-2

 

-3

 

Implanon / Nexplanon

 

170

 

178

 

155

 

183

 

686

 

134

 

164

 

148

 

160

 

606

 

14

 

13

 

13

 

13

 

Follistim AQ

 

81

 

79

 

72

 

66

 

298

 

94

 

73

 

101

 

87

 

355

 

-25

 

-27

 

-16

 

-16

 

Hospital and Specialty

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Hepatitis

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Zepatier

 

378

 

517

 

468

 

296

 

1,660

 

50

 

112

 

164

 

229

 

555

 

29

 

27

 

199

 

199

 

HIV

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Isentress / Isentress HD

 

305

 

282

 

310

 

308

 

1,204

 

340

 

338

 

372

 

337

 

1,387

 

-9

 

-11

 

-13

 

-14

 

Hospital Acute Care

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Bridion

 

148

 

163

 

185

 

209

 

704

 

90

 

113

 

139

 

139

 

482

 

50

 

49

 

46

 

46

 

Noxafil

 

141

 

155

 

162

 

179

 

636

 

145

 

143

 

147

 

161

 

595

 

11

 

8

 

7

 

7

 

Invanz

 

136

 

150

 

159

 

157

 

602

 

114

 

143

 

152

 

152

 

561

 

3

 

2

 

7

 

7

 

Cancidas

 

121

 

112

 

94

 

95

 

422

 

133

 

131

 

142

 

152

 

558

 

-37

 

-39

 

-24

 

-24

 

Cubicin

 

96

 

103

 

91

 

92

 

382

 

292

 

357

 

320

 

119

 

1,087

 

-22

 

-23

 

-65

 

-65

 

Primaxin

 

62

 

71

 

73

 

74

 

280

 

73

 

81

 

77

 

66

 

297

 

12

 

10

 

-6

 

-4

 

Immunology

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Remicade

 

229

 

208

 

214

 

186

 

837

 

349

 

339

 

311

 

269

 

1,268

 

-31

 

-35

 

-34

 

-34

 

Simponi

 

184

 

199

 

219

 

217

 

819

 

188

 

199

 

193

 

186

 

766

 

17

 

10

 

7

 

6

 

Oncology

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Keytruda

 

584

 

881

 

1,047

 

1,297

 

3,809

 

249

 

314

 

356

 

483

 

1,402

 

169

 

166

 

172

 

171

 

Emend

 

133

 

143

 

137

 

143

 

556

 

126

 

143

 

137

 

144

 

549

 

-1

 

-2

 

1

 

1

 

Temodar

 

66

 

65

 

68

 

73

 

271

 

66

 

73

 

78

 

67

 

283

 

10

 

11

 

-4

 

-4

 

Diversified Brands

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Respiratory

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Singulair

 

186

 

203

 

161

 

182

 

732

 

237

 

229

 

239

 

210

 

915

 

-13

 

-14

 

-20

 

-19

 

Nasonex

 

139

 

85

 

42

 

120

 

387

 

229

 

101

 

94

 

112

 

537

 

8

 

7

 

-28

 

-29

 

Dulera

 

82

 

69

 

59

 

77

 

287

 

113

 

121

 

97

 

105

 

436

 

-26

 

-27

 

-34

 

-34

 

Other

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cozaar / Hyzaar

 

112

 

119

 

128

 

125

 

484

 

126

 

132

 

131

 

121

 

511

 

3

 

2

 

-5

 

-4

 

Arcoxia

 

103

 

89

 

80

 

91

 

363

 

111

 

117

 

114

 

108

 

450

 

-16

 

-19

 

-19

 

-20

 

Fosamax

 

61

 

66

 

53

 

62

 

241

 

75

 

73

 

68

 

68

 

284

 

-9

 

-10

 

-15

 

-15

 

Vaccines (2)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Gardasil / Gardasil 9

 

532

 

469

 

675

 

633

 

2,308

 

378

 

393

 

860

 

542

 

2,173

 

17

 

15

 

6

 

6

 

ProQuad / M-M-R II / Varivax

 

355

 

399

 

519

 

403

 

1,676

 

357

 

383

 

496

 

405

 

1,640

 

0

 

-1

 

2

 

2

 

Pneumovax 23

 

163

 

166

 

229

 

263

 

821

 

107

 

120

 

175

 

238

 

641

 

11

 

11

 

28

 

29

 

RotaTeq

 

224

 

123

 

179

 

160

 

686

 

188

 

130

 

171

 

162

 

652

 

-1

 

-2

 

5

 

5

 

Zostavax

 

154

 

160

 

234

 

121

 

668

 

125

 

149

 

190

 

221

 

685

 

-45

 

-46

 

-2

 

-3

 

Other Pharmaceutical (3)

 

1,037

 

1,116

 

1,013

 

1,124

 

4,295

 

1,083

 

1,128

 

1,191

 

1,172

 

4,574

 

-4

 

-5

 

-6

 

-6

 

ANIMAL HEALTH

 

939

 

955

 

1,000

 

981

 

3,875

 

829

 

900

 

865

 

884

 

3,478

 

11

 

8

 

11

 

11

 

Other Revenues (4)

 

310

 

216

 

169

 

162

 

857

 

379

 

244

 

228

 

327

 

1,178

 

-51

 

-27

 

-27

 

-13

 

 

* 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 reflect 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, $87 million in the second quarter, $89 million in the third quarter, and $123 million in the fourth 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.