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EX-99.2 - EX-99.2 - Merck & Co., Inc.a18-12417_1ex99d2.htm
8-K - 8-K - Merck & Co., Inc.a18-12417_18k.htm

Exhibit 99.1

 

 

News Release

 

FOR IMMEDIATE RELEASE

 

Media Contacts:

Tracy Ogden

Investor Contacts:

Teri Loxam

 

(908) 740-1747

 

(908) 740-1986

 

 

 

 

 

Claire Gillespie
(267) 305-0932

 

Michael DeCarbo
(908) 740-1807

 

Merck Announces First-Quarter 2018 Financial Results

 

·                  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

 

KENILWORTH, N.J., May 1, 2018 — Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the first quarter of 2018.

 

“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

 


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.

 

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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.

 

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·                  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,

 

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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.

 

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First-Quarter Revenue Performance

 

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

 

 

 

First Quarter

 

$ in millions

 

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 HCl), 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.

 

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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

 

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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

 

GAAP

 

Acquisition- and
Divestiture-
Related Costs
4

 

Restructuring
Costs

 

Certain Other
Items

 

Non-GAAP2

 

First-Quarter 2018

 

 

 

 

 

 

 

 

 

 

 

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 20175

 

 

 

 

 

 

 

 

 

 

 

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

 


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.

 

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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

 

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(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.

 

 

 

First Quarter

 

$ in millions, except EPS amounts

 

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.

 


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.

 

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

 

 

 

GAAP

 

Non-GAAP2

 

 

 

 

 

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

 

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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).

 

###

 

Page 12


 


 

MERCK & CO., INC.

CONSOLIDATED STATEMENT OF INCOME - GAAP

(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)

(UNAUDITED)

Table 1

 

 

 

GAAP

 

 

 

 

 

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.