Merck Announces First-Quarter 2018 Financial Results

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May 1, 2018 5:45 am ET

Merck (NYSE: MRK), known as MSD outside the United States and Canada,
today announced financial results for the first quarter of 2018.

First-Quarter 2018 Worldwide Sales Were $10.0 Billion, an Increase of 6 Percent, Including a 3 Percent Positive Impact from Foreign Exchange
First-Quarter 2018 GAAP EPS was $0.27, Reflecting a $1.4 Billion Aggregate Charge Related to the Formation of a Collaboration with Eisai; First-Quarter Non-GAAP EPS was $1.05
Company Narrows and Raises 2018 Full-Year Revenue Range to be Between $41.8 Billion and $43.0 Billion, Including an Approximately 2 Percent Positive Impact from Foreign Exchange
Company Lowers 2018 GAAP EPS Range to be Between $2.45 and $2.57; Narrows and Raises 2018 Full-Year Non-GAAP EPS Range to be Between $4.16 and $4.28, Including an Approximately 1 Percent Positive Impact from Foreign Exchange
Results from Phase 3 KEYNOTE-189 Study Presented at AACR 2018 and Published in The New England Journal of Medicine Showed KEYTRUDA in Combination with Pemetrexed and Platinum Chemotherapy Reduced the Risk of Death by Half Compared with Chemotherapy Alone as a First-Line Treatment for Advanced Nonsquamous NSCLC
Data from KEYNOTE-189 is Now Under Review by Regulatory Authorities in the United States, Europe and Japan

“Merck had a strong start to the year driven by KEYTRUDA, GARDASIL,
BRIDION and Animal Health,” said Kenneth C. Frazier, Merck Chairman and
CEO. “This provides good momentum as we continue to execute on our
pillars of growth and look to deliver innovative medicines and vaccines
that address unmet needs for patients around the world.”

Financial Summary


	First Quarter
$ in millions, except EPS amounts	2018		2017
Sales	$	10,037	$	9,434
GAAP net income¹		736		1,551
Non-GAAP net income that excludes items listed below^1,2		2,844		2,437
GAAP EPS		0.27		0.56
Non-GAAP EPS that excludes items listed below²		1.05		0.88

Worldwide sales were $10.0 billion for the first quarter of 2018, an
increase of 6 percent compared with the first quarter of 2017, including
a 3 percent positive impact from foreign exchange.

GAAP (generally accepted accounting principles) earnings per share
assuming dilution (EPS) were $0.27 for the first quarter of 2018, which
reflects a $1.4 billion aggregate charge related to the formation of a
collaboration with Eisai Co., Ltd. (Eisai). Non-GAAP EPS of $1.05 for
the first quarter of 2018 excludes acquisition- and divestiture-related
costs, restructuring costs, the charge related to the Eisai
collaboration referenced above and certain other items.

Oncology Pipeline Highlights

Merck expanded its focus in oncology by further advancing the
development program for KEYTRUDA (pembrolizumab), the company’s
anti-PD-1 therapy, and Lynparza (olaparib), a PARP inhibitor being
co-developed and co-commercialized with AstraZeneca. The company
recently presented pivotal Phase 3 data for KEYTRUDA at the American
Association for Cancer Research (AACR) Annual Meeting. Additionally,
Merck and Eisai entered into a strategic collaboration for the worldwide
co-development and co-commercialization of Lenvima (lenvatinib
mesylate), an orally available tyrosine kinase inhibitor discovered by
Eisai. Eisai and Merck will develop and commercialize Lenvima jointly,
both as a monotherapy and in combination with KEYTRUDA.

Merck announced
results from KEYNOTE-189, a Phase 3 trial evaluating KEYTRUDA in
combination with pemetrexed and cisplatin or carboplatin for the
first-line treatment of metastatic nonsquamous non-small cell lung
cancer (NSCLC). Findings showed that the combination significantly
improved overall survival (OS), reducing the risk of death by half
compared with chemotherapy alone. In pre-specified exploratory
analyses, an OS benefit was observed regardless of PD-L1 expression in
the three PD-L1 categories that were evaluated. These results were
presented in a plenary session at the AACR Annual Meeting with
simultaneous publication in The New England Journal of
Medicine (NEJM).
Based on the KEYNOTE-189 data, the U.S. Food and Drug Administration
(FDA) granted
Priority Review for the supplemental Biologics License Application
(sBLA) for KEYTRUDA in combination with pemetrexed and platinum
chemotherapy for the first-line treatment of patients with metastatic
nonsquamous NSCLC with a PDUFA date of Sept. 23, 2018. Additionally,
Merck announced
that following validation by the European Medicines Agency (EMA), the
centralized review process has begun for the company’s Type II
Variation, which seeks approval for KEYTRUDA in combination with
pemetrexed and platinum cisplatin or carboplatin for the first-line
treatment of patients with metastatic nonsquamous NSCLC. The
application was accepted for review based on OS and progression-free
survival (PFS) data from the Phase 3 KEYNOTE-189 trial.
Merck announced
the Phase 3 KEYNOTE-042 trial evaluating KEYTRUDA as monotherapy for
the first-line treatment of locally advanced or metastatic NSCLC,
including nonsquamous or squamous histologies, met its primary
endpoint of OS. An interim analysis conducted by the independent Data
Monitoring Committee demonstrated that treatment with KEYTRUDA
resulted in significantly longer OS than platinum-based chemotherapy
(carboplatin plus paclitaxel or carboplatin plus pemetrexed) in
patients with a PD-L1 tumor proportion score (TPS) of ≥1 percent.
The FDA accepted for review a new sBLA for KEYTRUDA as a treatment in
previously treated patients with recurrent or metastatic head and neck
squamous cell carcinoma based on data from the Phase 3 KEYNOTE-040
trial. The FDA has set a PDUFA date of Dec. 28, 2018.
Merck and the European Organisation for Research and Treatment of
Cancer (EORTC), announced
findings from the Phase 3 EORTC1325/KEYNOTE-054 trial investigating
KEYTRUDA as adjuvant therapy in resected, high-risk stage III
melanoma. The results of the study showed KEYTRUDA significantly
prolonged recurrence-free survival, reducing the risk of disease
recurrence or death by 43 percent compared to placebo in the overall
study population. The results were presented in the opening plenary
session at the AACR Annual Meeting with simultaneous publication in NEJM.
Merck and Incyte Corporation announced
that an external Data Monitoring Committee (eDMC) review of the
pivotal Phase 3 ECHO-301/KEYNOTE-252 study results evaluating Incyte’s
epacadostat in combination with KEYTRUDA in patients with unresectable
or metastatic melanoma determined that the study did not meet the
primary endpoint of improving PFS in the overall population compared
to KEYTRUDA monotherapy. The study’s second primary endpoint of OS
also is not expected to reach statistical significance. Based on these
results, and at the recommendation of the eDMC, the study will be
stopped. The safety profile observed in ECHO-301/KEYNOTE-252 was
consistent with that observed in previously reported studies of
epacadostat in combination with KEYTRUDA.
The FDA accepted
a new sBLA and granted Priority Review for KEYTRUDA as a treatment for
patients with advanced cervical cancer with disease progression on or
after chemotherapy. The FDA has set a PDUFA date of June 28, 2018.
The 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, remains under
review with the FDA. The FDA has extended the PDUFA date by 90 days to
July 3, 2018 due to additional data and analyses submitted by Merck.
The Committee for Medicinal Products for Human Use of the EMA adopted
a positive opinion, recommending a marketing authorization of Lynparza
for use as a maintenance therapy for patients with platinum-sensitive
relapsed high grade, epithelial ovarian, fallopian tube, or primary
peritoneal cancer who are in complete response or partial response to
platinum-based chemotherapy.
The EMA validated
for review the Marketing Authorization Application for Lynparza for
use in patients with deleterious or suspected deleterious BRCA-mutated,
human epidermal growth factor receptor 2 (HER2)-negative metastatic
breast cancer who have been previously treated with chemotherapy in
the neoadjuvant, adjuvant or metastatic setting. This is the first
regulatory submission for a PARP inhibitor in breast cancer in Europe.
In January 2018, Lynparza was approved by the FDA for use in the
treatment of BRCA-mutated HER2-negative metastatic breast
cancer, becoming the first PARP inhibitor to be approved beyond
ovarian cancer.
The FDA granted
Orphan Drug Designation for selumetinib, a MEK 1/2 inhibitor being
co-developed with AstraZeneca, for the treatment of neurofibromatosis
type 1.
Merck and Viralytics Limited signed a definitive agreement
under which it is proposed that Merck will acquire Viralytics, an
Australian publicly traded company focused on oncolytic immunotherapy
treatments for a range of cancers. Upon completion of the transaction,
Merck will gain full rights to Cavatak (CVA21), Viralytics’s
investigational oncolytic immunotherapy.

Other Pipeline Highlights

The company also continued to advance its vaccines, HIV and infectious
diseases pipelines.

Merck announced
the beginning of two Phase 3 studies of V114, an investigational
polyvalent conjugate vaccine for the prevention of pneumococcal
disease. The first study will evaluate the safety, tolerability and
immunogenicity of V114 followed by Pneumococcal Vaccine Polyvalent one
year later in healthy adult subjects 50 years of age or older. The
second study will evaluate the safety, tolerability and immunogenicity
of V114 followed by Pneumococcal Vaccine Polyvalent administered eight
weeks later in adults infected with HIV. Results from Phase 1 and
Phase 2 studies were presented at the International Society on
Pneumococci and Pneumococcal Diseases.
Merck presented
data from its robust HIV pipeline, including doravirine, a late-stage
investigational non-nucleoside reverse transcriptase inhibitor, and
MK-8591, an investigational nucleoside reverse transcriptase
translocation inhibitor, at the Conference on Retroviruses and
Opportunistic Infections. Doravirine is currently under review with
the EMA and FDA with a PDUFA date of Oct. 23, 2018 in the United
States.
Merck announced
that a pivotal Phase 3 study of relebactam, the company’s
investigational beta-lactamase inhibitor, in combination with
imipenem/cilastatin, demonstrated a favorable overall response in the
treatment of certain imipenem–non-susceptible bacterial infections,
the primary endpoint, with lower treatment-emergent nephrotoxicity
(kidney toxicity), a secondary endpoint, compared to a Colistin
(colistimethate sodium) plus imipenem regimen. Based on these results,
the company plans to submit a New Drug Application to the FDA.

First-Quarter Revenue Performance

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


$ in millions	First Quarter
		2018		2017	Change		Change Ex-Exchange
Total Sales	$	10,037	$	9,434	6	%	3	%
Pharmaceutical		8,919		8,185	9	%	4	%
KEYTRUDA		1,464		584	151	%	142	%
JANUVIA / JANUMET		1,424		1,335	7	%	2	%
GARDASIL / GARDASIL 9		660		532	24	%	20	%
ZETIA / VYTORIN		471		575	-18	%	-26	%
PROQUAD, M-M-R II and VARIVAX		392		355	10	%	9	%
ISENTRESS / ISENTRESS HD		281		305	-8	%	-12	%
SIMPONI		231		184	26	%	11	%
NUVARING		216		160	36	%	32	%
BRIDION		204		148	38	%	31	%
Animal Health		1,065		939	13	%	7	%
Livestock		652		578	13	%	6	%
Companion Animals		413		361	14	%	9	%
Other Revenues		53		310	-83	%	-19	%

Pharmaceutical Revenue

First-quarter pharmaceutical sales increased 9 percent to $8.9 billion,
including a 5 percent positive impact from foreign exchange. The
increase was primarily driven by growth in oncology, hospital acute care
and diabetes, partially offset by lower sales in virology and the
ongoing impacts of the loss of market exclusivity for several products.

Growth in oncology was driven by a significant increase in sales of
KEYTRUDA, reflecting the company’s continued launches with new
indications globally and the strong momentum for the treatment of
patients with NSCLC, as KEYTRUDA is the only anti-PD-1 approved in the
first-line setting. Additionally, oncology sales reflect alliance
revenue of $33 million related to Lynparza.

Growth in hospital acute care reflects strong global demand 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.

Growth in diabetes was driven by JANUVIA (sitagliptin) and JANUMET
(sitagliptin and metformin HCI), medicines that help lower blood sugar
in adults with type 2 diabetes, reflecting growth in international
markets driven by higher demand, partially offset by pricing
pressure. Sales declines in the United States reflect continued pricing
pressure that was partially offset by volume growth, as well as a
favorable adjustment to rebate reserves.

Performance 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, reflecting growth in Asia Pacific, primarily due to the
commercial launch in China, and growth in Europe, partially offset by
lower sales in the United States. The decrease in GARDASIL/GARDASIL 9
sales in the United States was driven by declining volumes due to the
continued transition to the two-dose regimen. Vaccines performance was
negatively affected by a significant decrease in sales of ZOSTAVAX
(zoster vaccine live), a vaccine for the prevention of herpes zoster,
primarily due to the approval of a competitor product that received a
preferential recommendation from the U.S. Advisory Committee on
Immunization Practices in October 2017. The company anticipates that
future sales of ZOSTAVAX will continue to be unfavorably affected by
this competition.

Pharmaceutical sales growth in the quarter was partially offset by lower
sales in virology, largely reflecting a significant decline in ZEPATIER
(elbasvir and grazoprevir), a medicine for the treatment of chronic
hepatitis C virus genotypes 1 or 4 infection, due to increasing
competition and declining patient volumes, which the company expects to
continue.

Pharmaceutical sales growth for the quarter was also partially offset by
the ongoing impacts from the loss of United States 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.

Animal Health

Animal Health sales totaled $1.1 billion for the first quarter of 2018,
an increase of 13 percent compared with the first quarter of 2017,
including a 6 percent positive impact from foreign exchange. Growth was
driven by higher sales of livestock products, primarily ruminants and
poultry products, as well as higher sales of companion animal products.

In the first quarter of 2018, Animal Health became a reportable segment,
resulting in additional disclosure requirements under U.S. GAAP related
to segment performance, including segment profits. Animal Health segment
profits were $413 million in the first quarter of 2018, a decrease of 1
percent compared with $417 million in the first quarter of 2017.³

First-Quarter Expense, EPS and Related Information

The table below presents selected expense information.


$ in millions
First-Quarter 2018	GAAP			Acquisition- and Divestiture- Related Costs ⁴			Restructuring Costs		Certain Other Items			Non-GAAP ²
Materials and production	$	3,184			$734			$6		$–			$2,444
Marketing and administrative		2,508			8			1		—			2,499
Research and development		3,196			1			2		1,400			1,793
Restructuring costs		95			—			95		—			—
Other (income) expense, net		(291	)		(10	)		—		(22	)		(259	)

First-Quarter 2017 ⁵
Materials and production	$	3,049			$855			$63		$–			$2,131
Marketing and administrative		2,472			20			1		—			2,451
Research and development		1,830			11			—		—			1,819
Restructuring costs		151			—			151		—			—
Other (income) expense, net		(71	)		(3	)		—		(9	)		(59	)

GAAP Expense, EPS and Related Information

Gross margin was 68.3 percent for the first quarter of 2018 compared to
67.7 percent for the first quarter of 2017. The increase in gross margin
for the first quarter of 2018 was primarily driven by a lower net impact
of acquisition- and divestiture-related costs and restructuring costs
which reduced gross margin by 7.4 percentage points in the first quarter
of 2018 compared with 9.7 percentage points in the first quarter of
2017. The increase was partially offset by the amortization of
unfavorable manufacturing variances, in part resulting from the June
2017 cyber-attack, as well as the unfavorable effects of foreign
exchange.

Marketing and administrative expenses were $2.5 billion in the first
quarter of 2018, a 1 percent increase compared to the first quarter of
2017. The increase primarily reflects the unfavorable effects of foreign
exchange and higher administrative costs, reflecting the prioritization
of investment in growth products.

Research and development (R&D) expenses were $3.2 billion in the first
quarter of 2018 compared with $1.8 billion in the first quarter of 2017.
The increase was driven primarily by a $1.4 billion aggregate charge
related to the formation of the collaboration with Eisai, the
unfavorable effects of foreign exchange, increased clinical development
spending and investment in early drug development, partially offset by
lower licensing costs.

Other (income) expense, net, was $291 million of income in the first
quarter of 2018 compared to $71 million of income in the first quarter
of 2017. Other (income) expense, net, in the first quarter of 2018
reflects a gain from a legal settlement and the recognition of
unrealized gains on securities as a result of the adoption of a new
accounting standard for equity investments.

The effective income tax rate of 44.9 percent for the first quarter of
2018 reflects the unfavorable impact of the $1.4 billion aggregate
charge related to the formation of the Eisai collaboration for which no
tax benefit has been recognized.

GAAP EPS was $0.27 for the first quarter of 2018 compared with $0.56 for
the first quarter of 2017.

Non-GAAP Expense, EPS and Related Information

The non-GAAP gross margin was 75.7 percent for the first quarter of 2018
compared to 77.4 percent for the first quarter of 2017. The decrease in
non-GAAP gross margin was predominately due to the amortization of
unfavorable manufacturing variances, in part resulting from the June
2017 cyber-attack, as well as the unfavorable effects of foreign
exchange.

Non-GAAP marketing and administrative expenses were $2.5 billion in the
first quarter of 2018, an increase of 2 percent compared to the first
quarter of 2017. The increase in non-GAAP marketing and administrative
expenses was driven primarily by the unfavorable effects of foreign
exchange and higher administrative costs, reflecting the prioritization
of investment in growth products.

Non-GAAP R&D expenses were $1.8 billion in the first quarter of 2018, a
1 percent decrease compared to the first quarter of 2017. The decrease
primarily reflects lower licensing costs partially offset by the
unfavorable effects of foreign exchange, increased clinical development
spending and investment in early drug development.

Non-GAAP other (income) expense, net, was $259 million of income in the
first quarter of 2018 compared to $59 million of income in the first
quarter of 2017. Non-GAAP other (income) expense, net, in the first
quarter of 2018 reflects a gain from a legal settlement and the
recognition of unrealized gains on securities as a result of the
adoption of a new accounting standard for equity investments.

Non-GAAP EPS was $1.05 for the first quarter of 2018 compared with $0.88
for the first quarter of 2017.

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


$ in millions, except EPS amounts	First Quarter
	2018		2017
EPS
GAAP EPS	$0.27		$0.56
Difference⁶		0.78		0.32
Non-GAAP EPS that excludes items listed below²	$1.05		$0.88

Net Income
GAAP net income¹	$736		$1,551
Difference		2,108		886
Non-GAAP net income that excludes items listed below^1,2	$2,844		$2,437

Decrease (Increase) in Net Income Due to Excluded Items:
Acquisition- and divestiture-related costs⁴	$733		$883
Restructuring costs		104		215
Aggregate charge related to the formation of a collaboration with Eisai		1,400		—
Other		(22)		(9)
Net decrease (increase) in income before taxes		2,215		1,089
Estimated income tax (benefit) expense		(107)		(203)
Decrease (increase) in net income	$2,108		$886

Financial Outlook

Merck has narrowed and raised its full-year 2018 revenue range to be
between $41.8 billion and $43.0 billion, including an approximately 2
percent positive impact from foreign exchange at current exchange rates.

Merck has lowered its full-year 2018 GAAP EPS range to be between $2.45
and $2.57. The change in the GAAP EPS range reflects the inclusion of
the charge related to the collaboration with Eisai. Merck narrowed and
raised its full-year 2018 non-GAAP EPS range to be between $4.16 and
$4.28, including an approximately 1 percent positive impact from foreign
exchange at current exchange rates. The non-GAAP range excludes
acquisition- and divestiture-related costs, costs related to
restructuring programs, a charge related to the formation of the
collaboration with Eisai and certain other items.

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


	GAAP	Non-GAAP ²

Revenue	$41.8 to $43.0 billion	$41.8 to $43.0 billion**
Operating expenses	Lower than 2017 by a low-single digit rate	Higher than 2017 by a low- to mid-single digit rate
Effective tax rate	24.5% to 25.5%	19.0% to 20.0%
EPS	$2.45 to $2.57	$4.16 to $4.28
**The company does not have any non-GAAP adjustments to revenue.

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					$2.45 to $2.57
Difference⁶					1.71
Non-GAAP EPS that excludes items listed below²					$4.16 to $4.28

Acquisition- and divestiture-related costs⁴					$3,200
Restructuring costs					500
Aggregate charge related to the formation of a collaboration with Eisai					1,400
Net decrease (increase) in income before taxes					5,100
Estimated income tax (benefit) expense					(515)
Decrease (increase) in net income					$4,585

The expected full-year 2018 GAAP effective tax rate of 24.5 to 25.5
percent reflects an unfavorable impact of approximately 5.5 percentage
points from the above items.

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
9499465. Members of the media are invited to monitor the call by dialing
(706) 758-9928 or (800) 399-7917 and using ID code number 9499465.
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, Instagram,
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 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 2017 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).

###

¹ Net income attributable to Merck & Co., Inc.

² Merck is providing certain 2018 and 2017 non-GAAP
information that excludes certain items because of the nature of these
items and the impact they have on the analysis of underlying business
performance and trends. Management believes that providing this
information enhances investors’ understanding of the company’s results
as it permits investors to understand how management assesses
performance. Management uses these measures internally for planning and
forecasting purposes and to measure the performance of the company along
with other metrics. Senior management’s annual compensation is derived
in part using non-GAAP income and non-GAAP EPS. This information should
be considered in addition to, but not as a substitute for or superior
to, information prepared in accordance with GAAP. For a description of
the items, see Table 2a attached to this release.

³ Animal Health segment profits are comprised of segment
sales, less all materials and production costs, as well as marketing and
administrative expenses and research and development costs directly
incurred by the segment. For internal management reporting, Merck does
not allocate general and administrative expenses not directly incurred
by the segment, nor the cost of financing these activities. Separate
divisions maintain responsibility for monitoring and managing these
costs, including depreciation related to fixed assets utilized by these
divisions and, therefore, they are not included in segment profits.

⁴ 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.

⁵ On Jan. 1, 2018, the company adopted a new accounting
standard related to defined benefit plans. Upon adoption, net periodic
benefit cost/credit other than service cost was reclassified to Other
(income) expense, net from the previous classifications within Materials
and production costs, Marketing and administrative expenses and Research
and development costs. Previously reported amounts have been
reclassified to conform to the new presentation.

⁶ 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.

MERCK & CO., INC.
CONSOLIDATED STATEMENT OF INCOME – GAAP
(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)
(UNAUDITED)
Table 1

	GAAP						% Change
	1Q18			1Q17			% Change

Sales	$	10,037		$	9,434		6%

Costs, Expenses and Other
Materials and production ⁽¹⁾		3,184			3,049		4%
Marketing and administrative ⁽¹⁾		2,508			2,472		1%
Research and development ^{(1) (2)}		3,196			1,830		75%
Restructuring costs ⁽³⁾		95			151		-37%
Other (income) expense, net ⁽¹⁾		(291	)		(71	)	*
Income Before Taxes		1,345			2,003		-33%
Taxes on Income ⁽¹⁾		604			447
Net Income		741			1,556		-52%
Less: Net Income Attributable to Noncontrolling Interests		5			5
Net Income Attributable to Merck & Co., Inc.	$	736		$	1,551		-53%
Earnings per Common Share Assuming Dilution	$	0.27		$	0.56		-52%

Average Shares Outstanding Assuming Dilution		2,710			2,766
Tax Rate ⁽⁴⁾		44.9	%		22.3	%

* 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 in the first quarter of 2018 include a $1.4 billion aggregate charge related to the formation of a collaboration with Eisai Co., Ltd (Eisai).

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

⁽⁴⁾The effective income tax rate for the first quarter of 2018 reflects the unfavorable impact of a $1.4 billion aggregate pretax charge related to the formation of a collaboration with Eisai for which no tax benefit was recognized.

MERCK & CO., INC.
GAAP TO NON-GAAP RECONCILIATION
FIRST QUARTER 2018
(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)
(UNAUDITED)
Table 2a

	GAAP			Acquisition and Divestiture-Related Costs ⁽¹⁾			Restructuring Costs ⁽²⁾			Certain Other Items ⁽³⁾			Adjustment Subtotal		Non-GAAP
Materials and production	$	3,184		734			6						740		$	2,444
Marketing and administrative		2,508		8			1						9			2,499
Research and development		3,196		1			2			1,400			1,403			1,793
Restructuring costs		95					95						95			–
Other (income) expense, net		(291	)	(10	)					(22	)		(32	)		(259	)
Income Before Taxes		1,345		(733	)		(104	)		(1,378	)		(2,215	)		3,560
Income Tax Provision (Benefit)		604		(91	)	⁽⁴⁾	(21	)	⁽⁴⁾	5		⁽⁴⁾	(107	)		711
Net Income		741		(642	)		(83	)		(1,383	)		(2,108	)		2,849
Net Income Attributable to Merck & Co., Inc.		736		(642	)		(83	)		(1,383	)		(2,108	)		2,844
Earnings per Common Share Assuming Dilution	$	0.27		(0.24	)		(0.03	)		(0.51	)		(0.78	)	$	1.05

Tax Rate		44.9	%													20.0	%

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

Merck is providing certain non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing this information enhances investors’ understanding of the company’s results as it permits investors to understand how management assesses performance. Management uses these measures internally for planning and forecasting purposes and to measure the performance of the company along with other metrics. Senior management’s annual compensation is derived in part using non-GAAP income and non-GAAP EPS. This information should be considered in addition to, but not as a substitute for or superior to, information prepared in accordance with GAAP.

⁽¹⁾Amounts included in materials and production costs 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 reflect increases in the estimated fair value measurement of liabilities for contingent consideration. Amounts included in other (income) expense, net reflect royalty income, partially offset by an increase in the estimated fair value measurement of liabilities for contingent consideration.

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

⁽³⁾ Amount included in research and development expenses represents an aggregate charge related to the formation of a collaboration with Eisai Co., Ltd.

⁽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.

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

	2018		2017										1Q
	1Q		1Q		2Q		3Q		4Q		Full Year		Nom %	Ex-Exch %

TOTAL SALES ⁽¹⁾	$	10,037	$	9,434	$	9,930	$	10,325	$	10,433	$	40,122	6	3
PHARMACEUTICAL		8,919		8,185		8,759		9,156		9,290		35,390	9	4
Oncology
Keytruda		1,464		584		881		1,047		1,297		3,809	151	142
Emend		125		133		143		137		143		556	-5	-9
Temodar		57		66		65		68		73		271	-13	-18
Alliance Revenue – Lynparza		33						5		16		20
Vaccines ⁽²⁾
Gardasil / Gardasil 9		660		532		469		675		633		2,308	24	20
ProQuad / M-M-R II / Varivax		392		355		399		519		403		1,676	10	9
RotaTeq		193		224		123		179		160		686	-14	-15
Pneumovax 23		179		163		166		229		263		821	9	7
Zostavax		65		154		160		234		121		668	-58	-60
Hospital Acute Care
Bridion		204		148		163		185		209		704	38	31
Noxafil		176		141		155		162		179		636	24	17
Invanz		151		136		150		159		157		602	11	8
Cubicin		98		96		103		91		92		382	2	-2
Cancidas		91		121		112		94		95		422	-25	-31
Primaxin		72		62		71		73		74		280	15	9
Immunology
Simponi		231		184		199		219		217		819	26	11
Remicade		167		229		208		214		186		837	-27	-35
Neuroscience
Belsomra		54		42		52		56		60		210	31	27
Virology
Isentress / Isentress HD		281		305		282		310		308		1,204	-8	-12
Zepatier		131		378		517		468		296		1,660	-65	-69
Cardiovascular
Zetia		305		334		367		320		323		1,344	-9	-17
Vytorin		167		241		182		142		186		751	-31	-38
Atozet		73		49		63		59		54		225	47	30
Adempas		68		84		67		70		79		300	-19	-25
Diabetes ⁽³⁾
Januvia		880		839		948		1,012		938		3,737	5	1
Janumet		544		496		563		513		586		2,158	10	4
Women’s Health
NuvaRing		216		160		199		214		188		761	36	32
Implanon / Nexplanon		174		170		178		155		183		686	2	1
Diversified Brands
Singulair		175		186		203		161		182		732	-6	-12
Nasonex		122		139		85		42		120		387	-12	-17
Cozaar / Hyzaar		120		112		119		128		125		484	7	0
Arcoxia		83		103		89		80		91		363	-20	-25
Follistim AQ		67		81		79		72		66		298	-17	-22
Dulera		57		82		69		59		77		287	-31	-31
Fosamax		55		61		66		53		62		241	-9	-17
Other Pharmaceutical ⁽⁴⁾		989		995		1,064		952		1,048		4,065	-1	-6

ANIMAL HEALTH		1,065		939		955		1,000		981		3,875	13	7
Livestock		652		578		591		647		668		2,484	13	6
Companion Animals		413		361		364		353		313		1,391	14	9

Other Revenues ⁽⁵⁾		53		310		216		169		162		857	-83	-19

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

⁽¹⁾ Only select products are shown.

⁽²⁾ Total Vaccines sales were $1,561 million in the first quarter of 2018 and $1,516 million, $1,404 million, $1,924 million and $1,704 million for the first, second, third and fourth quarters of 2017, respectively.

⁽³⁾ Total Diabetes sales were $1,433 million in the first quarter of 2018 and $1,338 million, $1,520 million, $1,531 million and $1,533 million for the first, second, third and fourth quarters of 2017, respectively.

⁽⁴⁾ Includes Pharmaceutical products not individually shown above.

⁽⁵⁾ Other Revenues are comprised primarily of Healthcare Services segment revenues, third-party manufacturing sales and miscellaneous corporate revenues, including revenue hedging activities.