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 below1,2         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 below1,2 $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 TwitterFacebookInstagram,
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
   
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.



Merck
Media:
Tracy Ogden, (908) 740-1747
Claire Gillespie, (267) 305-0932
or
Investor:
Teri Loxam, (908) 740-1986
Michael DeCarbo, (908) 740-1807

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