Merck Announces Third-Quarter 2018 Financial Results

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October 25, 2018 5:45 am ET

  • Third-Quarter 2018 Worldwide Sales Were $10.8 Billion
  • Third-Quarter 2018 GAAP EPS was $0.73, Third-Quarter Non-GAAP EPS was $1.19
  • Company Narrows 2018 Full-Year Revenue Range to be Between $42.1 Billion and $42.7 Billion, Including a Minimal Impact from Foreign Exchange
  • Company Narrows and Lowers 2018 Full-Year GAAP EPS Range to be Between $2.41 and $2.47; Narrows and Raises 2018 Full-Year Non-GAAP EPS Range to be Between $4.30 and $4.36, Including an Approximately 1 Percent Negative Impact from Foreign Exchange
  • Results from KEYNOTE-426 Studying KEYTRUDA in Combination with Axitinib as First-line Treatment for Advanced or Metastatic Renal Cell Carcinoma Met Primary Endpoints of Overall Survival and Progression-Free Survival
  • Company Announces 15 Percent Increase to Quarterly Dividend to 55 Cents Per Outstanding Share and Authorizes an Additional $10 Billion Share Repurchase, Including a $5 Billion Accelerated Share Repurchase Program

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada,
today announced financial results for the third quarter of 2018.

“We built on our strong momentum during the quarter and believe that
Merck is well-positioned to continue creating sustainable value for
shareholders and patients,” said Kenneth C. Frazier, Merck Chairman and
CEO. “Our focused execution is driving our operational results, with
KEYTRUDA making a difference to cancer patients around the world. We are
also continuing to advance our broad pipeline, including in oncology,
vaccines, hospital and specialty as well as animal health. With this
strong performance, we are highly confident in our portfolio, strategy
and pipeline as demonstrated by our announced capital return actions
today.”

Financial Summary

      Third Quarter
$ in millions, except EPS amounts     2018         2017  
Sales   $ 10,794 $ 10,325  

GAAP net income (loss)1

 

  1,950   (56 )
Non-GAAP net income that excludes items listed below1,2     3,178   3,054  
GAAP EPS     0.73   (0.02 )

Non-GAAP EPS that excludes items listed below2

    1.19   1.11  

Worldwide sales were $10.8 billion for the third quarter of 2018, an
increase of 5 percent compared with the third quarter of 2017, including
a 1 percent negative impact from foreign exchange. The sales increase in
the third quarter of 2018 was partially attributable to a reduction in
sales in the third quarter of 2017 of approximately $240 million due to
a borrowing from the U.S. Centers for Disease Control and Prevention
(CDC) Pediatric Vaccine Stockpile of GARDASIL 9 (Human Papillomavirus
9-valent Vaccine, Recombinant), a vaccine to prevent certain HPV-related
cancers and other diseases, driven in part by the temporary production
shutdown resulting from the cyber-attack that occurred in June of 2017,
as well as overall higher demand than originally planned. Additionally,
sales in the third quarter of 2017 were unfavorably affected by
approximately $135 million from lost revenue in certain markets related
to the cyber-attack.

GAAP (generally accepted accounting principles) earnings (loss) per
share assuming dilution (EPS) were $0.73 for the third quarter of 2018.
Non-GAAP EPS of $1.19 for the third quarter of 2018 excludes
acquisition- and divestiture-related costs, restructuring costs, a
charge of $420 million related to the termination of a collaboration
agreement with Samsung Bioepis Co., Ltd. (Samsung) for insulin glargine
and certain other items. Year-to-date results can be found in the
attached tables.

Oncology Pipeline Highlights

Merck continued to expand its oncology program by further advancing the
development programs for KEYTRUDA (pembrolizumab), the company’s
anti-PD-1 therapy; Lynparza (olaparib), a PARP inhibitor being
co-developed and co-commercialized with AstraZeneca; and Lenvima
(lenvatinib mesylate), an orally available tyrosine kinase inhibitor
being co-developed and co-commercialized with Eisai Co., Ltd. (Eisai).

KEYTRUDA

  • Merck announced
    that based on the results of the KEYNOTE-189 trial, the U.S. Food and
    Drug Administration (FDA) and the European Commission (EC) approved
    KEYTRUDA in combination with pemetrexed and platinum chemotherapy for
    the first-line treatment of patients with metastatic nonsquamous
    non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor
    aberrations.
  • Merck announced
    that the FDA granted priority review to a new supplemental Biologics
    License Application seeking approval for KEYTRUDA as monotherapy for
    first-line treatment of locally advanced or metastatic nonsquamous or
    squamous NSCLC in patients whose tumors express PD-L1 (tumor
    proportion score [TPS] ≥1%) without EGFR or ALK genomic tumor
    aberrations, based on the results of the pivotal Phase 3 KEYNOTE-042
    trial. The FDA set a PDUFA date of Jan. 11, 2019.
  • Merck announced
    top-line results from KEYNOTE-426, a pivotal Phase 3 trial studying
    KEYTRUDA in combination with Pfizer’s axitinib as first-line treatment
    for advanced or metastatic renal cell carcinoma. KEYNOTE-426 met its
    primary endpoints of overall survival (OS) and progression-free
    survival (PFS) demonstrating that the combination made a statistically
    significant and clinically meaningful improvement in survival versus
    sunitinib.
  • Merck announced
    interim results from KEYNOTE-048, a pivotal Phase 3 trial studying
    KEYTRUDA as both monotherapy and in combination with chemotherapy, for
    the first-line treatment of recurrent or metastatic head and neck
    squamous cell carcinoma. KEYNOTE-048 met its primary endpoint
    demonstrating that monotherapy and combination therapy showed
    significantly improved OS compared to the standard of care. These
    results were presented at the European Society for Medical Oncology
    (ESMO) 2018 Congress.
  • Merck announced
    that the Committee for Medicinal Products for Human Use (CHMP) of the
    European Medicines Agency (EMA) adopted a positive opinion for
    KEYTRUDA as adjuvant therapy in the treatment of patients with
    melanoma based on the significant recurrence-free survival benefit
    demonstrated with KEYTRUDA in the pivotal Phase 3
    EORTC1325/KEYNOTE-054 trial.
  • Merck announced
    the first presentation of results from KEYNOTE-057, a Phase 2 trial
    evaluating KEYTRUDA in previously-treated patients with high-risk
    non-muscle invasive bladder cancer at the ESMO 2018 Congress. KEYTRUDA
    demonstrated a complete response rate of nearly 40 percent.

Lynparza

  • Merck and AstraZeneca announced
    detailed results from the Phase 3 SOLO-1 trial testing Lynparza as a
    maintenance treatment for patients with newly-diagnosed advanced BRCA-mutated
    ovarian cancer who were in complete or partial response following
    first-line standard platinum-based chemotherapy. Results of the trial
    confirm the statistically-significant and clinically-meaningful
    improvement in PFS for Lynparza as compared to placebo, reducing the
    risk of disease progression or death by 70 percent. At 41 months of
    follow-up, the median PFS for patients treated with Lynparza was not
    reached compared to 13.8 months for patients treated with placebo.
    These results were presented at the ESMO 2018 Congress and published
    simultaneously online in the New England Journal of Medicine.

Lenvima

  • Merck and Eisai announced
    that the FDA approved Lenvima for the first-line treatment of patients
    with unresectable hepatocellular carcinoma. Lenvima was also approved
    for the same use in China
    by the China National Drug Administration and in Europe
    by the EC.
  • Merck and Eisai announced
    that the FDA granted Breakthrough Therapy Designation for Lenvima in
    combination with KEYTRUDA for the potential treatment of
    patients with advanced and/or metastatic non-microsatellite
    instability high/proficient mismatch repair endometrial carcinoma who
    have progressed following at least one prior systemic therapy. This is
    the third Breakthrough Therapy Designation for Lenvima and the second
    Breakthrough Therapy Designation for Lenvima in combination with
    KEYTRUDA.

Other Oncology Pipeline Highlights

Clinical data from Merck’s early pipeline was presented at the ESMO 2018
Congress in October and additional data on other programs will be
presented at the Society for Immunotherapy of Cancer (SITC) 2018 meeting
in November.

  • At ESMO 2018, Merck presented a number of datasets from its early
    pipeline:

    • STING agonist (MK-1454) first-in-human data
      from Merck’s Phase 1 program studying it as a monotherapy and in
      combination with KEYTRUDA in patients with advanced solid tumors
      or lymphomas;
    • RIG-I (MK-4621) data from Merck’s Phase 1/2 trial studying it in
      advanced or recurrent tumors;
    • CAVATAK data from Merck’s Phase 1 KEYNOTE-200 trial studying it in
      combination with KEYTRUDA for treatment of NSCLC and bladder
      cancer; and
    • CTLA-4 (MK-1308) data from Merck’s Phase 1 trial studying it in
      combination with KEYTRUDA for treatment of advanced solid tumors.
  • At SITC 2018, Merck will be presenting:

    • LAG3 (MK-4280) data from Merck’s Phase 1 trial studying it as
      monotherapy and in combination with KEYTRUDA for the treatment of
      advanced solid tumors;
    • TIGIT (MK-7684) data from Merck’s Phase 1 trial studying it as
      monotherapy and in combination with KEYTRUDA for the treatment of
      patients with solid tumors; and
    • ILT4 (MK-4830) pre-clinical data.

Other Pipeline Highlights

The company continued to advance its vaccines, antibiotics and HIV
pipelines.

  • The FDA approved an expanded age indication for GARDASIL 9 for use in
    women and men ages 27 through 45.
  • Merck announced
    that the pivotal Phase 3 clinical study evaluating the company’s
    antibiotic ZERBAXA (ceftolozane and tazobactam) at an investigational
    dose for the treatment of adult patients with either ventilated
    hospital-acquired bacterial pneumonia or ventilator-associated
    bacterial pneumonia met the pre-specified primary endpoints,
    demonstrating non-inferiority to meropenem, the active comparator, in
    day 28 all-cause mortality and in clinical cure rate at the
    test-of-cure visit. Based on these results, Merck plans to submit
    supplemental new drug applications to the FDA and EMA seeking
    regulatory approval of ZERBAXA for these potential new indications.
  • Merck announced
    that the FDA approved two new HIV-1 medicines indicated for the
    treatment of HIV-1 infection in adult patients with no prior
    antiretroviral treatment experience: DELSTRIGO, a once-daily
    fixed-dose combination tablet of doravirine (100 mg), lamivudine (3TC,
    300 mg) and tenofovir disoproxil fumarate (TDF, 300 mg); and PIFELTRO
    (doravirine, 100 mg), a new non-nucleoside reverse transcriptase
    inhibitor to be administered in combination with other antiretroviral
    medicines. The CHMP of the EMA adopted
    a positive opinion recommending granting of marketing authorization
    for DELSTRIGO and PIFELTRO for the treatment of adults with HIV-1
    infection without past or present evidence of resistance to the
    non-nucleoside reverse transcriptase class, lamivudine or tenofovir.

Third-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       Third Quarter
2018       2017       Change       Change

Ex-Exchange

Total Sales $ 10,794 $ 10,325 5 % 6 %
Pharmaceutical 9,658 9,156 5 % 7 %
KEYTRUDA 1,889 1,047 80 % 82 %
JANUVIA / JANUMET 1,490 1,525 -2 % -1 %
GARDASIL / GARDASIL 9 1,048 675 55 % 56 %
PROQUAD,

M-M-R II and VARIVAX

525

519

1

%

2

%

ISENTRESS / ISENTRESS HD 275 310 -11 % -9 %
ZETIA / VYTORIN 257 462 -44 % -43 %
NUVARING 234 214 9 % 10 %
BRIDION 217 185 17 % 20 %
PNEUMOVAX 23 214 229 -7 % -6 %
SIMPONI 210 219 -4 % -3 %
Animal Health 1,021 1,000 2 % 6 %
Livestock 660 655 1 % 5 %
Companion Animals 361 345 5 % 7 %

Other Revenues

        115         169       -32 %       -21 %

Pharmaceutical Revenue

Third-quarter pharmaceutical sales increased 5 percent to $9.7 billion,
including a 2 percent negative impact from foreign exchange. In addition
to the factors mentioned in the Financial Summary above, the increase
was primarily driven by growth in oncology and hospital acute care,
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 $49 million related to Lynparza and $43 million related to
Lenvima, representing Merck’s share of profits, which are product sales
net of cost of sales and commercialization costs.

Growth in hospital acute care reflects strong demand in the United
States for 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, and strong global
demand for NOXAFIL (posaconazole), a medicine for the prevention of
invasive fungal infections.

Vaccines performance reflects higher sales of GARDASIL [Human
Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine,
Recombinant] and GARDASIL 9, vaccines to prevent certain cancers and
other diseases caused by HPV, in the United States attributable to the
CDC stockpile borrowing in the third quarter of 2017 as described
previously, and growth in international markets, primarily due to higher
sales in Europe and the ongoing commercial launch in China. 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 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 market exclusivity for ZETIA
(ezetimibe) and VYTORIN (ezetimibe/simvastatin), medicines for lowering
LDL cholesterol; and biosimilar competition for REMICADE (infliximab), a
treatment for inflammatory diseases, in the company’s marketing
territories in Europe.

Animal Health

Animal Health sales totaled $1.0 billion for the third quarter of 2018,
an increase of 2 percent compared with the third quarter of 2017,
including a 4 percent negative impact from foreign exchange. Growth was
primarily driven by higher sales of companion animal products,
predominantly from the BRAVECTO (fluralaner) line of products that kill
fleas and ticks in dogs and cats for up to 12 weeks. Growth was also
driven by higher sales of livestock products including ruminants and
poultry products.

Animal Health segment profits were $409 million in the third quarter of
2018, an increase of 5 percent compared with $389 million in the third
quarter of 2017.3

Third-Quarter Expense, EPS and Related Information

The table below presents selected expense information.

 
$ in millions

Third-Quarter 2018

     

 

GAAP

     

Acquisition- and

Divestiture-Related


Costs

4

     

Restructuring

Costs

     

Certain Other

Items

     

 

Non-GAAP
2

Materials and production $ 3,619 $ 680 $ 2 $ 420 $ 2,517
Marketing and administrative 2,443 2 2,441
Research and development 2,068 5 (4) 2,067
Restructuring costs 171 171
Other (income) expense, net (172 ) (10) (162)
 

Third-Quarter 2017
5

Materials and production $ 3,307 $ 768 $ 25 $ $ 2,514
Marketing and administrative 2,459 11 2,448
Research and development 4,413 271 2 2,350 1,790
Restructuring costs 153 153
Other (income) expense, net         (207 )         (18)                         (189)

GAAP Expense, EPS and Related Information

Gross margin was 66.5 percent for the third quarter of 2018 compared to
68.0 percent for the third quarter of 2017. The decrease in gross margin
for the third quarter of 2018 was primarily driven by the charge related
to the termination of a collaboration agreement with Samsung. The
decrease was partially offset by the favorable effects of foreign
exchange, as well as costs recorded in the third quarter of 2017 related
to the cyber-attack. In addition, a lower net impact of acquisition- and
divestiture-related costs and restructuring costs, which reduced gross
margin by 6.3 percentage points in the third quarter of 2018 compared
with 7.7 percentage points in the third quarter of 2017, also partially
offset the margin decline.

Marketing and administrative expenses were $2.4 billion in the third
quarter of 2018, a decline of 1 percent compared to the third quarter of
2017, reflecting lower direct selling and promotion costs, as well as
the favorable effects of foreign exchange, largely offset by higher
administrative costs.

Research and development (R&D) expenses were $2.1 billion in the third
quarter of 2018 compared with $4.4 billion in the third quarter of 2017.
The decline primarily reflects a $2.35 billion charge recorded in the
third quarter of 2017 related to the formation of a collaboration with
AstraZeneca and lower in-process research and development (IPR&D)
impairment charges, partially offset by increased clinical development
spending, in particular for oncology, higher licensing costs and
investment in discovery and early drug development.

GAAP EPS was $0.73 for the third quarter of 2018 compared with $(0.02)
for the third quarter of 2017.

Non-GAAP Expense, EPS and Related Information

The non-GAAP gross margin was 76.7 percent for the third quarter of 2018
compared to 75.7 percent for the third quarter of 2017. The increase was
predominantly due to the favorable effects of foreign exchange, as well
as costs recorded in the third quarter of 2017 related to the
cyber-attack.

Non-GAAP marketing and administrative expenses were $2.4 billion in the
third quarter of 2018, comparable to the third quarter of 2017,
reflecting lower direct selling and promotion costs, as well as the
favorable effects of foreign exchange, offset by higher administrative
costs.

Non-GAAP R&D expenses were $2.1 billion in the third quarter of 2018, an
increase of 15 percent compared to the third quarter of 2017. The
increase primarily reflects higher clinical development spending, in
particular for oncology, higher licensing costs and investment in
discovery and early drug development.

Non-GAAP EPS was $1.19 for the third quarter of 2018 compared with $1.11
for the third 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       Third Quarter
2018       2017
EPS
GAAP EPS $ 0.73 $ (0.02 )

Difference6

0.46 1.13
Non-GAAP EPS that excludes items listed below2 $ 1.19 $ 1.11
 
Net Income
GAAP net income (loss)1 $ 1,950 $ (56 )
Difference 1,228 3,110
Non-GAAP net income that excludes items listed below1,2 $ 3,178 $ 3,054
 
Decrease (Increase) in Net Income Due to Excluded Items:

Acquisition- and divestiture-related costs4

$ 677 $ 1,032
Restructuring costs 169 180
Charge related to the termination of a collaboration agreement with
Samsung
420
Charge related to the formation of a collaboration with AstraZeneca 2,350
Net decrease (increase) in income before taxes 1,266 3,562

Income tax (benefit) expense7

(38 ) (452 )
Decrease (increase) in net income       $ 1,228         $ 3,110  

Financial Outlook

Merck narrowed its full-year 2018 revenue range to be between $42.1
billion and $42.7 billion, including a minimal impact from foreign
exchange at current exchange rates.

Merck narrowed and lowered its full-year 2018 GAAP EPS range to be
between $2.41 and $2.47. The change in the GAAP EPS range reflects the
inclusion of the charge related to the termination of the collaboration
agreement with Samsung. Merck narrowed and raised its full-year 2018
non-GAAP EPS range to be between $4.30 and $4.36, including an
approximately 1 percent negative impact from foreign exchange at current
exchange rates. The non-GAAP range excludes acquisition- and
divestiture-related costs, costs related to restructuring programs,
charges related to the formation of the Eisai collaboration and the
Viralytics acquisition, a charge related to the termination of a
collaboration agreement with Samsung and certain other items.

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

 
      GAAP         Non-GAAP
2
 
Revenue $42.1 to $42.7 billion $42.1 to $42.7 billion*
Operating expenses Lower than 2017 by a low- to mid-single digit rate Higher than 2017 by a low- to mid-single digit rate
Effective tax rate 26.0% to 27.0% 19.0% to 20.0%
EPS**       $2.41 to $2.47         $4.30 to $4.36
 

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

**EPS guidance for 2018 assumes a share count (assuming dilution)
of approximately 2.7 billion shares.

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 $2.41 to $2.47
Difference6 1.89
Non-GAAP EPS that excludes items listed below2 $4.30 to $4.36
 
Acquisition- and divestiture-related costs4 $ 2,800
Restructuring costs 550
Charge related to the formation of a collaboration with Eisai 1,400
Charge related to the termination of a collaboration agreement with
Samsung
420
Charge for Viralytics acquisition 344
Net decrease (increase) in income before taxes 5,514
Estimated income tax (benefit) expense (460)
Decrease (increase) in net income         $ 5,054

The expected full-year 2018 GAAP effective tax rate of 26.0 percent to
27.0 percent reflects an unfavorable impact of approximately 7.0
percentage points from the above items.

Capital Allocation

Merck’s Board of Directors has approved a 15 percent increase to the
company’s quarterly dividend, raising it to $0.55 per share from $0.48
per share of the company’s outstanding common stock. Payment will be
made on Jan. 8, 2019, to shareholders of record at the close of business
on Dec. 17, 2018. The Board also authorized an additional $10 billion of
treasury stock purchases with no time limit for completion. The company
has entered into a $5 billion accelerated share repurchase program under
its expanded authorization.

In addition, the company also plans to now invest approximately $16
billion on new capital projects through 2022, up $4 billion from its
prior $12 billion commitment announced in February.

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 https://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
2169459. Members of the media are invited to monitor the call by dialing
(706) 758-9928 or (800) 399-7917 and using ID code number 2169459.
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 (loss) 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.

7 Includes the estimated tax impact on the reconciling items.
In addition, amount for third quarter 2017 includes a $234 million net
tax benefit related to the settlement of certain federal income tax
issues.

MERCK & CO., INC.
CONSOLIDATED STATEMENT OF INCOME – GAAP
(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)
(UNAUDITED)
Table 1
                                                         
GAAP         % Change         GAAP         % Change
3Q18         3Q17 Sep YTD 2018       Sep YTD 2017
Sales $ 10,794 $ 10,325 5% $ 31,296 $ 29,689 5%
 
Costs, Expenses and Other
Materials and production (1) (2) 3,619 3,307 9% 10,220 9,472 8%
Marketing and administrative (1) 2,443 2,459 -1% 7,459 7,432
Research and development (1) (3) 2,068 4,413 -53% 7,538 8,024 -6%
Restructuring costs (4) 171 153 12% 494 470 5%
Other (income) expense, net (1) (172 ) (207 ) -17% (512 ) (351 ) 46%
Income Before Taxes 2,665 200 * 6,097 4,642 31%
Taxes on Income (1) 707 251 1,682 1,186
Net Income (Loss) 1,958 (51 ) * 4,415 3,456 28%
Less: Net Income Attributable to Noncontrolling Interests 8 5 22 16
Net Income (Loss) Attributable to Merck & Co., Inc. $ 1,950 $ (56 ) * $ 4,393 $ 3,440 28%
Earnings (Loss) per Common Share Assuming Dilution (5) $ 0.73   $ (0.02 ) * $ 1.63   $ 1.25   30%
       
Average Shares Outstanding Assuming Dilution (5) 2,678 2,727 2,694 2,754
Tax Rate (6)   26.5 %   125.5 %   27.6 %   25.5 %
 
* 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) Materials and production costs in the third quarter
and first nine months of 2018 include a $420 million aggregate
charge related to the termination of a collaboration agreement with
Samsung Bioepis Co., Ltd. (Samsung) for insulin glargine.
 
(3) Research and development expenses in the first nine
months of 2018 include a $1.4 billion aggregate charge related to
the formation of a collaboration with Eisai Co., Ltd. (Eisai), as
well as a $344 million charge for the acquisition of Viralytics
Limited. Research and development expenses for the third quarter and
first nine months of 2017 include a $2.35 billion aggregate charge
related to the formation of a collaboration with AstraZeneca PLC
(AstraZeneca).
 
(4) Represents separation and other related costs
associated with restructuring activities under the company’s formal
restructuring programs.
 
(5) Because the company recorded a net loss in the third
quarter of 2017, no potential dilutive common shares were used in
the computation of loss per common share assuming dilution as the
effect would have been anti-dilutive.
 
(6) The effective income tax rates for the third quarter
and first nine months of 2018 include the unfavorable impact of a
$420 million aggregate pretax charge related to the termination of a
collaboration agreement with Samsung for which no tax benefit was
recognized. The effective income tax rate for the first nine months
of 2018 also 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. The effective
income tax rates for the third quarter and first nine months of 2017
reflect the unfavorable impact of a $2.35 billion aggregate pretax
charge related to the formation of a collaboration with AstraZeneca
for which no tax benefit was recognized, partially offset by the
favorable impact of a net tax benefit of $234 million related to the
settlement of certain federal income tax issues.
MERCK & CO., INC.
GAAP TO NON-GAAP RECONCILIATION
THIRD 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 $ 3,619 680 2 420 1,102 $ 2,517
Marketing and administrative 2,443 2 2 2,441
Research and development 2,068 5 (4) 1 2,067
Restructuring costs 171 171 171
Other (income) expense, net (172) (10) (10) (162)
Income Before Taxes 2,665 (677) (169) (420) (1,266) 3,931
Income Tax Provision (Benefit) 707 (26) (4) (20) (4) 8 (38) 745
Net Income 1,958 (651) (149) (428) (1,228) 3,186
Net Income Attributable to Merck & Co., Inc. 1,950 (651)

(149)

(428) (1,228) 3,178
Earnings per Common Share Assuming Dilution $ 0.73 (0.24) (0.06) (0.16) (0.46) $ 1.19
   
Tax Rate 26.5% 18.9%
 
 
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 primarily reflect an increase in the estimated fair value
measurement of liabilities for contingent consideration. Amounts
included in other (income) expense, net primarily reflect royalty
income, partially offset by an increase in the estimated fair value
measurement of liabilities for contingent consideration related to
the termination of the Sanofi-Pasteur MSD joint venture.
 
(2) Amounts primarily include employee separation costs
and accelerated depreciation associated with facilities to be closed
or divested related to activities under the company’s formal
restructuring programs.
 
(3) Amount included in materials and production costs
represents an aggregate charge related to the termination of a
collaboration agreement with Samsung Bioepis Co., Ltd. for insulin
glargine.
 
(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.
GAAP TO NON-GAAP RECONCILIATION
NINE MONTHS ENDED SEPTEMBER 30, 2018
(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)
(UNAUDITED)
Table 2b
                                                           
GAAP

Acquisition and

Divestiture-Related


Costs


(1)

Restructuring

Costs

(2)

Certain Other

Items

(3)

Adjustment

Subtotal

Non-GAAP
Materials and production $ 10,220 2,147 11 420 2,578 $ 7,642
Marketing and administrative 7,459 26 2 28 7,431
Research and development 7,538 7 1 1,744 1,752 5,786
Restructuring costs 494 494 494
Other (income) expense, net (512 ) 85 (54 ) 31 (543 )
Income Before Taxes 6,097 (2,265 ) (508 ) (2,110 ) (4,883 ) 10,980
Income Tax Provision (Benefit) 1,682 (230 )

(4

)

(69 )

(4

)

(101

)

(4

)

(400

) 2,082
Net Income 4,415 (2,035 ) (439 ) (2,009 ) (4,483 ) 8,898
Net Income Attributable to Merck & Co., Inc. 4,393 (2,035 ) (439 ) (2,009 ) (4,483 ) 8,876
Earnings per Common Share Assuming Dilution $ 1.63   (0.75 ) (0.16 ) (0.75 ) (1.66 ) $ 3.29  
   
Tax Rate   27.6 %   19.0 %
 
 
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 primarily reflect an increase in the estimated fair value
measurement of liabilities for contingent consideration. Amounts
included in other (income) expense, net primarily reflect an
increase in the estimated fair value measurement of liabilities for
contingent consideration, partially offset by royalty income related
to the termination of the Sanofi-Pasteur MSD joint venture.
 
(2) Amounts primarily include employee separation costs
and accelerated depreciation associated with facilities to be closed
or divested related to activities under the company’s formal
restructuring programs.
 
(3) Amount included in materials and production costs
represents an aggregate charge related to the termination of a
collaboration agreement with Samsung Bioepis Co., Ltd. for insulin
glargine. Amounts included in research and development expenses
represent a $1.4 billion aggregate charge related to the formation
of a collaboration with Eisai Co., Ltd., as well as a $344 million
charge for the acquisition of Viralytics Limited.
 
(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)
(UNAUDITED)
Table 3
                           
 

2018

2017

3Q

Sep YTD
1Q 2Q 3Q Sep YTD 1Q 2Q 3Q Sep YTD 4Q Full Year Nom % Ex-Exch % Nom % Ex-Exch %
TOTAL SALES

(1)
$10,037 $10,465 $10,794 $31,296 $9,434 $9,930 $10,325 $29,689 $10,433 $40,122 5 6 5 5
PHARMACEUTICAL 8,919 9,282 9,658 27,859 8,185 8,759 9,156 26,101 9,290 35,390 5 7 7 5
Oncology
Keytruda 1,464 1,667 1,889 5,020 584 881 1,047 2,512 1,297 3,809 80 82 100 97
Emend 125 148 123 396 133 143 137 413 143 556 -10 -10 -4 -6
Temodar 57 56 46 159 66 65 68 198 73 271 -32 -30 -20 -21
Alliance Revenue – Lynparza 33 44 49 125 5 5 16 20 * * * *
Alliance Revenue – Lenvima 35 43 78 * 100 * 100
Vaccines

(2)
Gardasil / Gardasil 9 660 608 1,048 2,317 532 469 675 1,675 633 2,308 55 56 38 36
ProQuad / M-M-R II / Varivax 392 426 525 1,343 355 399 519 1,273 403 1,676 1 2 5 5
Pneumovax 23 179 193 214 586 163 166 229 558 263 821 -7 -6 5 4
RotaTeq 193 156 191 540 224 123 179 525 160 686 7 8 3 2
Zostavax 65 44 54 163 154 160 234 547 121 668 -77 -77 -70 -71
Hospital Acute Care
Bridion 204 240 217 661 148 163 185 495 209 704 17 20 33 31
Noxafil 176 188 188 551 141 155 162 458 179 636 16 18 21 18
Invanz 151 149 137 437 136 150 159 445 157 602 -14 -12 -2 -2
Cubicin 98 94 95 287 96 103 91 290 92 382 4 6 -1 -3
Cancidas 91 87 79 257 121 112 94 327 95 422 -16 -14 -22 -25
Primaxin 72 68 72 212 62 71 73 206 74 280 -1 0 3 -1
Immunology
Simponi 231 233 210 673 184 199 219 602 217 819 -4 -3 12 5
Remicade 167 157 135 459 229 208 214 651 186 837 -37 -35 -29 -33
Neuroscience
Belsomra 54 71 66 191 42 52 56 150 60 210 17 17 27 25
Virology
Isentress / Isentress HD 281 305 275 860 305 282 310 896 308 1,204 -11 -9 -4 -5
Zepatier 131 113 104 347 378 517 468 1,363 296 1,660 -78 -77 -75 -76
Cardiovascular
Zetia 305 226 165 696 334 367 320 1,021 323 1,344 -48 -48 -32 -36
Vytorin 167 155 92 414 241 182 142 565 186 751 -35 -34 -27 -31
Atozet 73 101 84 258 49 63 59 171 54 225 42 44 51 42
Adempas 68 75 94 238 84 67 70 221 79 300 35 35 7 4
Diabetes

(3)
Januvia 880 949 927 2,756 839 948 1,012 2,799 938 3,737 -8 -8 -2 -3
Janumet 544 585 563 1,693 496 563 513 1,572 586 2,158 10 12 8 6
Women’s Health
NuvaRing 216 236 234 686 160 199 214 573 188 761 9 10 20 19
Implanon / Nexplanon 174 174 186 535 170 178 155 503 183 686 20 22 6 6
Diversified Brands
Singulair 175 185 161 521 186 203 161 550 182 732 0 1 -5 -9
Cozaar / Hyzaar 120 125 103 348 112 119 128 360 125 484 -20 -18 -3 -6
Nasonex 122 81 71 274 139 85 42 266 120 387 67 73 3 0
Arcoxia 83 84 83 249 103 89 80 272 91 363 3 7 -8 -10
Follistim AQ 67 70 60 198 81 79 72 232 66 298 -16 -15 -15 -17
Fosamax 55 59 45 159 61 66 53 180 62 241 -16 -14 -12 -15
Dulera 57 42 50 149 82 69 59 210 77 287 -15 -14 -29 -29
Other Pharmaceutical

(4)
989 1,053 980 3,023 995 1,064 952 3,017 1,048 4,065 3 6 0 -1
*
ANIMAL HEALTH 1,065 1,090 1,021 3,176 939 955 1,000 2,894 981 3,875 2 6 10 8
Livestock 652 633 660 1,946 578 582 655 1,816 668 2,484 1 5 7 6
Companion Animals 413 457 361 1,230 361 373 345 1,078 313 1,391 5 7 14 12
 
Other Revenues

(5)
53 93 115 261 310 216 169 694 162 857 -32 -21 -62 -16
 
* 200% or greater
 
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, $1,533
million and $2,159 million in the first, second and third quarters
of 2018, respectively, 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, $1,571
million and $1,506 million in the first, second and third quarters
of 2018, respectively, 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:
Claire Gillespie, (267) 305-0932
or
Investor:
Teri Loxam, (908) 740-1986
Michael DeCarbo, (908) 740-1807

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