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UNITED STATESSECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORTPursuant to Section 13 or 15(d) ofthe Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) May 2, 2017
Merck & Co., Inc.(Exact Name of Registrant as Specified in Its Charter)
New Jersey
(State or Other Jurisdiction of Incorporation)
1-6571
22-1918501(Commission File Number)
(I.R.S. Employer Identification No.)
2000 Galloping Hill Road, Kenilworth, NJ
07033(Address of Principal Executive Offices)
(Zip Code)
Registrant’s Telephone Number, Including Area Code (908) 740-4000
Not Applicable(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the followingprovisions: o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) orRule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company o If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new orrevised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
Item 2.02. Results of Operations and Financial Condition . The following information, including the exhibits hereto, is being furnished pursuant to this Item 2.02. Incorporated by reference is a press release issued by the Registrant on May 2, 2017, regarding earnings for the first quarter of 2017, attached as Exhibit 99.1. Alsoincorporated by reference is certain supplemental information not included in the press release, attached as Exhibit 99.2. This information shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), orotherwise subject to the liabilities of that Section, and is not incorporated by reference in any filing under the Securities Act of 1933, as amended, or the ExchangeAct, except as expressly set forth by specific reference in such filing. Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit 99.1 Press release issued May 2, 2017, regarding earnings for the first quarter of 2017 Exhibit 99.2 Certain supplemental information not included in the press release
2
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized. Merck & Co., Inc.
Date:May 2, 2017 By: /s/ Karen L. Mealey
KAREN L. MEALEY
Assistant Secretary
3
EXHIBIT INDEX
Exhibit
Number
Description 99.1
Press release issued May 2, 2017, regarding earnings for the first quarter of 2017 99.2
Certain supplemental information not included in the press release
4
Exhibit 99.1
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 firstquarter of 2017.
“Merck delivered solid performance across our broad range of products that address major disease categories and the needs of global health,” saidKenneth C. Frazier, chairman and chief executive officer, Merck. “The continued momentum of KEYTRUDA in oncology, along with the strength of the vaccineand 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 items *
0.88
0.89
GAAP net income
1,551
1,125
Non-GAAP net income that excludes certain items *
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 keyregulatory 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 withrefractory 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 ofKEYTRUDA for the treatment of adult patients with relapsed or refractory cHL who have failed autologous
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 onthe analysis of underlying business performance and trends. Management believes that providing this information enhances investors’ understanding of thecompany’s results as it permits investors to understand how management assesses performance. Management uses these measures internally for planning andforecasting purposes and to measure the performance of the company along with other metrics. Senior management’s annual compensation is derived in partusing non-GAAP income and non-GAAP EPS. This information should be considered in addition to, but not as a substitute for or superior to, informationprepared in accordance with GAAP. For a description of the items, see Table 2a attached to this release. Net income attributable to Merck & Co., Inc.
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1
2
1,2
1
2
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 ofKEYTRUDA 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 forPriority 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 3clinical trial evaluating the safety and efficacy of doravirine (MK-1439), an investigational non-nucleoside reverse transcriptase inhibitor for previouslyuntreated 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, alsoknown as shingles. The data demonstrated a reduction in the incidence of confirmed HZ cases by an estimated
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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 wasdriven 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 4infection, due to ongoing launches globally. Sales in the United States also reflect an approximately $40 million favorable adjustment to rebate accruals due to mixof 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 previouslypart 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 thathelp 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 allergysymptoms; as well as by the ongoing impact of biosimilar competition in the company’s marketing territories in Europe for REMICADE (infliximab), a treatmentfor 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 1percent 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 Healthcompleted the acquisition of Vallée S.A., a leading privately held producer of animal health products in Brazil.
Page 5
First-Quarter Expense, EPS and Related Information
The table below presents selected expense information.
$ in millions
GAAP
Acquisition- and Divestiture- Related Costs
Restructuring Costs
Certain Other Items
Non-GAAP
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 ingross margin for the first quarter of 2017 was primarily driven by a lower net impact from acquisition- and divestiture-related costs and restructuring costs whichreduced 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 ingross 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. Theincrease 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. Theincrease 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.
Includes expenses for the amortization of intangible assets and purchase accounting adjustments to inventories recognized as a result of acquisitions, intangibleasset impairment charges and expense or income related to changes in the estimated fair value measurement of contingent consideration. Also includesintegration, transaction and certain other costs related to business acquisitions and divestitures.
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3 1
3
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 of2016. 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 increaseprimarily 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
Difference
0.32
0.49
Non-GAAP EPS that excludes items listed below
$0.88
$0.89
Net Income
GAAP net income
$1,551
$1,125
Difference
886
1,367
Non-GAAP net income that excludes items listed below
$2,437
$2,492
Decrease (Increase) in Net Income Due to Excluded Items:
Acquisition- and divestiture-related costs
$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.
Represents the difference between calculated GAAP EPS and calculated non-GAAP EPS, which may be different than the amount calculated by dividing theimpact of the excluded items by the weighted-average shares for the period.
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1
2
1,2
3
4
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-GAAP
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
Difference
1.25
Non-GAAP EPS that excludes items listed below
$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 IDcode 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 beeninventing 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 alsodemonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at theforefront 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.comand 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 safeharbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of thecompany’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products willreceive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks oruncertainties 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 andcurrency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; globaltrends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new productdevelopment, 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 innovativeproducts; 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 orotherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be
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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 theSEC’s Internet site ( www.sec.gov ).
###
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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
3,015
3,572
-16%Marketing and administrative
2,411
2,318
4%Research and development
1,796
1,659
8%Restructuring costs
151
91
66%Other (income) expense, net
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.
(1)
(1)
(1)
(2)
(1)
MERCK & CO., INC.
GAAP TO NON-GAAP RECONCILIATIONFIRST QUARTER 2017
(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)(UNAUDITED)
Table 2a
GAAP
Acquisition and Divestiture-Related
Costs
Restructuring Costs
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) (48) 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 AssumingDilution
$ 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 ofunderlying business performance and trends. Management believes that providing this information enhances investors’ understanding of the company’s results as itpermits investors to understand how management assesses performance. Management uses these measures internally for planning and forecasting purposes and tomeasure 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 ofacquisitions, 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, aswell as transaction and certain other costs related to business divestitures. Amounts included in research and development expenses primarily reflect changes in theestimated 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 underthe 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.
(1) (2)
(3) (3) (3)
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
$ 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
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
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
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. Only select products are shown.
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. 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. Other Revenues are comprised primarily of alliance revenue, third-party manufacturing sales and miscellaneous corporate revenues, including revenue hedging activities.
(1)
(2)
(3)
(4)
*
(1)
(2)
(3)
(4)
Exhibit 99.2
MERCK & CO., INC.CONSOLIDATED STATEMENT OF INCOME - GAAP
(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)(UNAUDITED)
Table 1a
2017
2016
% Change
1Q
1Q
2Q
3Q
4Q
Full Year
1Q
Sales
$ 9,434
$ 9,312
$ 9,844
$ 10,536
$ 10,115
$ 39,807
1% Costs, Expenses and Other
Materials and production
3,015
3,572
3,578
3,409
3,332
13,891
-16%Marketing and administrative
2,411
2,318
2,458
2,393
2,593
9,762
4%Research and development
1,796
1,659
2,151
1,664
4,650
10,124
8%Restructuring costs
151
91
134
161
265
651
66%Other (income) expense, net
58
48
19
22
631
720
21%Income (Loss) Before Taxes
2,003
1,624
1,504
2,887
(1,356) 4,659
23%Income Tax Provision (Benefit)
447
494
295
699
(769) 718
Net Income (Loss)
1,556
1,130
1,209
2,188
(587) 3,941
38%Less: Net Income Attributable toNoncontrolling Interests
5
5
4
4
7
21
Net Income (Loss) Attributable to Merck &Co., Inc.
$ 1,551
$ 1,125
$ 1,205
$ 2,184
$ (594) $ 3,920
38%Earnings (Loss) per Common Share AssumingDilution
$ 0.56
$ 0.40
$ 0.43
$ 0.78
$ (0.22) $ 1.41
40% Average Shares Outstanding AssumingDilution
2,766
2,795
2,789
2,786
2,755
2,787
Tax Rate
22.3% 30.4% 19.6% 24.2% 56.7% 15.4%
Sum of quarterly amounts may not equal year-to-date amounts due to rounding. (1) Because the company recorded a net loss in the fourth quarter of 2016, no potential dilutive common shares were used in the computation of loss per commonshare assuming dilution as the effect would have been anti-dilutive.
(1)
(1)
MERCK & CO., INC.
GAAP TO NON-GAAP RECONCILIATION FIRST QUARTER 2016
(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES) (UNAUDITED)
Table 2b
GAAP
Acquisition and Divestiture-
Related Costs
Restructuring Costs
Adjustment Subtotal
Non-GAAP
Materials and production
$ 3,572
1,386
47
1,433
$ 2,139
Marketing and administrative
2,318
2
3
5
2,313
Research and development
1,659
35
55
90
1,569
Restructuring costs
91
91
91
—
Other (income) expense, net
48
48
Income Before Taxes
1,624
(1,423) (196) (1,619) 3,243
Income Tax Provision (Benefit)
494
(209) (43) (252) 746
Net Income
1,130
(1,214) (153) (1,367) 2,497
Net Income Attributable to Merck & Co., Inc.
1,125
(1,214) (153) (1,367) 2,492
Earnings per Common Share Assuming Dilution
$ 0.40
(0.43) (0.06) (0.49) $ 0.89
Tax Rate
30.4%
23.0% 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 ofunderlying business performance and trends. Management believes that providing this information enhances investors’ understanding of the company’s results as itpermits investors to understand how management assesses performance. Management uses these measures internally for planning and forecasting purposes and tomeasure 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 reflect $1.1 billion of expenses for the amortization of intangible assets recognized as a result ofacquisitions, as well as $24 million of amortization of purchase accounting adjustments to inventories related to the 2015 acquisition of CubistPharmaceuticals, Inc., and $252 million of intangible asset impairment charges. 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, aswell as transaction and certain other costs related to business divestitures. Amounts included in research and development expenses primarily reflect in-processresearch and development (IPR&D) impairment charges. (2) Amounts primarily include employee separation costs and accelerated depreciation associated with facilities to be closed or divested related to activities underthe company’s formal restructuring programs. (3) Represents the estimated tax impact of the reconciling items based on applying the statutory rate of the originating territory of the non-GAAP adjustments.
(1) (2)
(3) (3)
MERCK & CO., INC.
FRANCHISE / KEY PRODUCT SALES FIRST QUARTER 2017
(AMOUNTS IN MILLIONS) Table 3a
Global
U.S.
International
1Q 2017
1Q 2016
% Change
1Q 2017
1Q 2016
% Change
1Q 2017
1Q 2016
% Change
TOTAL SALES
$ 9,434
$ 9,312
1
$ 4,195
$ 4,222
-1
$ 5,239
$ 5,090
3
PHARMACEUTICAL
8,185
8,104
1
3,761
3,913
-4
4,424
4,191
6
Primary Care and Women’s
Health
Cardiovascular
Zetia
334
612
-46
111
386
-71
222
226
-2
Vytorin
241
277
-13
90
109
-18
151
168
-10
Liptruzet
49
23
114
49
23
114
Adempas
84
33
158
84
33
158
Diabetes
Januvia
839
906
-7
507
549
-8
332
357
-7
Janumet
496
506
-2
195
226
-14
302
280
8
General Medicine &Women’s Health
Implanon / Nexplanon
170
134
27
132
99
32
39
35
12
NuvaRing
160
175
-9
113
128
-12
47
48
-1
Follistim AQ
81
94
-14
42
53
-21
40
42
-4
Hospital and Specialty
Hepatitis
Zepatier
378
50
*
200
49
*
178
1
*
HIV
Isentress
305
340
-10
143
162
-12
162
178
-9
Hospital Acute Care
Bridion
148
90
63
45
5
*
102
86
19
Noxafil
141
145
-3
65
71
-8
76
74
3
Invanz
136
114
20
82
65
26
54
49
10
Cancidas
121
133
-9
5
4
20
116
128
-10
Cubicin
96
292
-67
54
255
-79
41
37
13
Primaxin
62
73
-15
1
-57
62
73
-14
Immunology
Remicade
229
349
-34
229
349
-34
Simponi
184
188
-2
184
188
-2
Oncology
Keytruda
584
249
134
361
133
172
223
116
92
Emend
133
126
6
86
82
5
47
44
7
Temodar
66
66
1
4
-78
65
62
6
Diversified Brands
Respiratory
Singulair
186
237
-22
6
17
-66
180
220
-18
Nasonex
139
229
-40
18
112
-84
121
117
3
Dulera
82
113
-27
75
107
-29
7
6
18
Other
Cozaar / Hyzaar
112
126
-11
3
6
-48
109
121
-9
Arcoxia
103
111
-7
103
111
-7
Fosamax
61
75
-19
1
1
62
60
74
-20
Vaccines
Gardasil / Gardasil 9
532
378
41
398
320
25
134
58
130
ProQuad / M-M-R II /Varivax
355
357
298
310
-4
57
47
21
RotaTeq
224
188
19
178
149
20
45
39
16
Pneumovax 23
163
107
52
114
67
70
49
40
22
Zostavax
154
125
23
109
109
45
16
174
Other Pharmaceutical
1,037
1,083
-4
329
334
-1
709
745
-5
ANIMAL HEALTH
939
829
13
283
233
22
656
596
10
Other Revenues
310
379
-18
151
76
99
159
303
-48
* 200% or greater Only select products are shown.
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. Includes Pharmaceutical products not individually shown above. Other Vaccines sales included in Other Pharmaceutical were $88 million and $103 million on a global basis for first quarter
2017 and 2016, respectively. Other Revenues are comprised primarily of alliance revenue, third-party manufacturing sales and miscellaneous corporate revenues, including revenue hedging activities.
(1)
(2)
(3)
(4)
(1)
(2)
(3)
(4)
MERCK & CO., INC.
PHARMACEUTICAL GEOGRAPHIC SALES(AMOUNTS IN MILLIONS)
(UNAUDITED)Table 3b
2017
2016
% Change
1Q
1Q
2Q
3Q
4Q
Full Year
1Q
TOTAL PHARMACEUTICAL
$ 8,185
$ 8,104
$ 8,700
$ 9,443
$ 8,904
$ 35,151
1
United States
3,761
3,913
4,169
4,710
4,282
17,073
-4
% Pharmaceutical Sales
45.9% 48.3% 47.9% 49.9% 48.1% 48.6%
Europe
1,977
1,914
1,997
1,935
1,843
7,689
3
% Pharmaceutical Sales
24.2% 23.6% 23.0% 20.5% 20.7% 21.9%
Japan
688
620
673
812
659
2,764
11
% Pharmaceutical Sales
8.4% 7.7% 7.7% 8.6% 7.4% 7.9%
Asia Pacific
889
806
890
914
912
3,522
10
% Pharmaceutical Sales
10.9% 9.9% 10.2% 9.7% 10.2% 10.0%
China
328
337
353
350
333
1,374
-3
Latin America
375
359
430
448
538
1,776
5
% Pharmaceutical Sales
4.6% 4.4% 4.9% 4.7% 6.0% 5.1%
Eastern Europe/Middle East Africa
255
272
314
364
429
1,379
-6
% Pharmaceutical Sales
3.1% 3.4% 3.6% 3.9% 4.8% 3.9%
Canada
182
147
170
184
180
682
23
% Pharmaceutical Sales
2.2% 1.8% 2.0% 1.9% 2.0% 1.9%
Other
58
73
57
76
61
266
-21
% Pharmaceutical Sales
0.7% 0.9% 0.7% 0.8% 0.7% 0.8%
Europe primarily represents all European Union countries and the European Union accession markets.
(1)
(1)
MERCK & CO., INC.
OTHER (INCOME) EXPENSE, NET - GAAP(AMOUNTS IN MILLIONS)
(UNAUDITED) Table 4
OTHER (INCOME) EXPENSE, NET
1Q17
1Q16
INTEREST INCOME
$ (97) $ (79)INTEREST EXPENSE
182
172
EXCHANGE (GAINS) LOSSES
(8) 38
EQUITY LOSS (INCOME) FROM AFFILIATES
13
(34)Other, net
(32) (49)TOTAL
$ 58
$ 48