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EX-99.2 - EX-99.2 - Merck & Co., Inc.a18-17779_1ex99d2.htm
8-K - 8-K - Merck & Co., Inc.a18-17779_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 Second-Quarter 2018 Financial Results

 

·                  Second-Quarter 2018 Worldwide Sales Were $10.5 Billion, an Increase of 5 Percent, Including a 1 Percent Positive Impact from Foreign Exchange

 

·                  Second-Quarter 2018 GAAP EPS was $0.63, Second-Quarter Non-GAAP EPS was $1.06

 

·                  Company Narrows 2018 Full-Year Revenue Range to be Between $42.0 Billion and $42.8 Billion, Including a Slightly Positive Impact from Foreign Exchange

 

·                  Company Narrows and Raises 2018 Full-Year GAAP EPS Range to be Between $2.51 and $2.59; Narrows and Raises 2018 Full-Year Non-GAAP EPS Range to be Between $4.22 and $4.30; Both Include an Approximately 1 Percent Negative Impact from Foreign Exchange

 

·                  Continued Leadership in NSCLC with Positive Results from Phase 3 KEYNOTE-407 and KEYNOTE-042 Studies Presented at ASCO 2018 Evaluating KEYTRUDA as a First-Line Treatment for NSCLC; sBLA for KEYNOTE-407 Under Priority Review in the United States with an Oct. 30, 2018 PDUFA Date

 

·                  KEYTRUDA Approved in China for the Treatment of Adult Patients with Unresectable or Metastatic Melanoma Following Failure of One Prior Line of Therapy; First and Only Anti-PD-1 Therapy Approved in China for Advanced Melanoma

 

KENILWORTH, N.J., July 27, 2018 — Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the second quarter of 2018.

 

“Strong commercial execution globally for KEYTRUDA, GARDASIL, BRIDION and other products led the company to deliver growth in the second quarter,” said Kenneth C. Frazier, Merck Chairman and CEO. “We continue to solidify our leadership in immuno-oncology and, along with our other key pillars of growth including Animal Health, we are confident in the strength of our business.”

 



 

Financial Summary

 

 

 

Second Quarter

 

$ in millions, except EPS amounts

 

2018

 

2017

 

Sales

 

$10,465

 

$9,930

 

GAAP net income1

 

1,707

 

1,946

 

Non-GAAP net income that excludes items listed below1,2

 

2,854

 

2,778

 

GAAP EPS

 

0.63

 

0.71

 

Non-GAAP EPS that excludes items listed below2

 

1.06

 

1.01

 

 

Worldwide sales were $10.5 billion for the second quarter of 2018, an increase of 5 percent compared with the second quarter of 2017, including a 1 percent positive impact from foreign exchange.

 

GAAP (generally accepted accounting principles) earnings per share assuming dilution (EPS) were $0.63 for the second quarter of 2018. Non-GAAP EPS of $1.06 for the second quarter of 2018 excludes acquisition- and divestiture-related costs, restructuring costs 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 Inc. (Eisai).

 

KEYTRUDA

 

·                  Merck announced that the U.S. Food and Drug Administration (FDA) accepted for review a supplemental Biologics License Application (sBLA) for KEYTRUDA as a first-line treatment for metastatic squamous non-small cell lung cancer (NSCLC), regardless of PD-L1 expression. The sBLA, which is seeking accelerated approval for this new indication, is based on overall response rate (ORR) data from the pivotal Phase 3 KEYNOTE-407 trial, which were recently presented at the American Society of Clinical Oncology (ASCO) 2018

 


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.

 

Page 2



 

Annual Meeting. The FDA granted Priority Review and set a PDUFA date of Oct. 30, 2018. Additional data showing a significant improvement in overall survival (OS) were also presented, making this the fifth study in advanced NSCLC in which KEYTRUDA demonstrated an improved survival benefit.

 

·                  Merck announced results from KEYNOTE-042, a pivotal Phase 3 study evaluating KEYTRUDA as monotherapy for the first-line treatment of locally advanced or metastatic nonsquamous or squamous NSCLC with PD-L1 tumor proportion score of >1 percent without EGFR or ALK genomic tumor aberrations. In this study, KEYTRUDA monotherapy resulted in significantly longer OS than platinum-based chemotherapy. These results were presented in the plenary session and during the press program at ASCO 2018.

 

·                  Merck announced interim data from a cohort of the Phase 2 KEYNOTE-158 study evaluating KEYTRUDA as monotherapy in patients with previously treated advanced small cell lung cancer (SCLC). Findings showed an ORR, the primary endpoint of the study, of 18.7 percent in patients in the SCLC cohort. Additionally, in a pre-specified exploratory analysis, ORR was 35.7 percent in patients whose tumors expressed PD-L1 with a combined positive score (CPS) of >1. These results, as well as other findings from the KEYNOTE-158 cohort in SCLC, were presented for the first time at ASCO 2018.

 

·                  The company announced that the pivotal Phase 3 KEYNOTE-048 trial investigating KEYTRUDA for first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), met a primary endpoint of OS as monotherapy in patients whose tumors expressed PD-L1 (CPS>20). KEYTRUDA is the first anti-PD-1 therapy to show an OS benefit as first-line therapy for recurrent or metastatic HNSCC. At the time of the interim analysis, the dual-primary endpoint of progression-free survival (PFS) for patients whose tumors expressed PD-L1 (CPS>20) had not been reached. These results will be presented at an upcoming medical meeting and submitted to regulatory authorities worldwide.

 

·                  Merck announced that KEYTRUDA has been approved by the China National Drug Administration for the treatment of adult patients with unresectable or metastatic melanoma following failure of one prior line of therapy. This is the first and only approval of an anti-PD-1 therapy for advanced melanoma in China.

 

·                  The FDA accepted and granted Priority Review for a new sBLA seeking approval for KEYTRUDA as a treatment for previously treated patients with advanced hepatocellular carcinoma, based on data from the Phase 2 KEYNOTE-224 trial, which were presented at ASCO 2018. The FDA set a PDUFA date of Nov. 9, 2018.

 

Page 3



 

·                  Merck announced that the FDA accepted for standard review a new sBLA for KEYTRUDA as adjuvant therapy in the treatment of patients with resected, high-risk stage III melanoma and granted a PDUFA date of Feb. 16, 2019. This sBLA is based on a significant benefit in recurrence-free survival demonstrated by KEYTRUDA in the pivotal Phase 3 EORTC1325/ KEYNOTE-054 trial, which was conducted in collaboration with the European Organisation for Research and Treatment of Cancer.

 

·                  The FDA approved KEYTRUDA for two new indications under its accelerated approval regulations based on tumor response rate and durability of response:

 

·                  For the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma, or who have relapsed after two or more prior lines of therapy.

·                  For the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 as determined by an FDA-approved test.

 

Lynparza

 

·                  Merck and AstraZeneca announced positive results from the randomized, double-blinded, placebo-controlled, Phase 3 SOLO-1 trial of Lynparza tablets, showing women with BRCA-mutated (BRCAm) advanced ovarian cancer treated first-line with Lynparza maintenance therapy had a statistically significant and clinically meaningful improvement in PFS compared to placebo.

 

·                  Merck and AstraZeneca announced that Japan’s Pharmaceuticals and Medical Devices Agency approved Lynparza tablets for use in patients with unresectable or recurrent BRCAm, human epidermal growth factor receptor 2 (HER2)-negative breast cancer who have received prior chemotherapy.

 

·                  Merck and AstraZeneca announced that the European Medicines Agency approved Lynparza tablets 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, regardless of BRCA status.

 

·                  Merck and AstraZeneca presented data from the Phase 2 Study 08 trial, which showed clinical improvement in median radiologic PFS with Lynparza in combination with abiraterone compared to abiraterone monotherapy, a current standard of care, in metastatic castration-resistant prostate cancer.

 

Page 4



 

Lenvima

 

·                  Merck and Eisai announced results from presentations of new data and analyses of Lenvima in combination with KEYTRUDA in four different tumor types: unresectable hepatocellular carcinoma, squamous cell carcinoma of the head and neck, advanced renal cell carcinoma and advanced endometrial carcinoma. The data were included in presentations at ASCO 2018.

 

Other Pipeline Highlights

 

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

 

·                  Merck announced that the FDA accepted for review a new sBLA for GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant), the company’s nine-valent HPV vaccine, for an expanded age indication for use in women and men 27 to 45 years old for the prevention of certain cancers and diseases caused by the nine human papillomavirus (HPV) types covered by the vaccine. The FDA granted Priority Review and set a PDUFA date of Oct. 6, 2018.

 

·                  China’s Food and Drug Administration approved GARDASIL 9 for use in girls and women 16 to 26 years old.

 

·                  Merck announced Week 96 results from the Phase 3 DRIVE-FORWARD clinical trial evaluating the efficacy and safety of doravirine (DOR), the company’s investigational non-nucleoside reverse transcriptase inhibitor, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in adult patients with no prior antiretroviral treatment history. At Week 96, 73.1 percent of the group treated with once-daily DOR plus FTC/TDF or ABC/3TC achieved viral suppression as measured by the proportion of patients who achieved HIV-1 RNA of less than 50 copies/mL, compared to 66.0 percent of the group treated with once-daily ritonavir-boosted darunavir (DRV+r) plus FTC/TDF or ABC/3TC. These study results were presented as a late-breaking abstract at the recent 22nd International AIDS Conference.

 

Second-Quarter Revenue Performance

 

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

 

Page 5



 

 

 

Second Quarter

 

 

 

 

 

 

 

 

 

Change

 

$ in millions

 

2018

 

2017

 

Change

 

Ex-Exchange

 

Total Sales

 

$10,465

 

$9,930

 

5

%

4

%

Pharmaceutical

 

9,282

 

8,759

 

6

%

3

%

KEYTRUDA

 

1,667

 

881

 

89

%

86

%

JANUVIA / JANUMET

 

1,535

 

1,511

 

2

%

-1

%

GARDASIL / GARDASIL 9

 

608

 

469

 

30

%

26

%

PROQUAD, M-M-R II and VARIVAX

 

426

 

399

 

7

%

6

%

ZETIA / VYTORIN

 

381

 

549

 

-31

%

-35

%

ISENTRESS / ISENTRESS HD

 

305

 

282

 

8

%

6

%

BRIDION

 

240

 

163

 

48

%

45

%

NUVARING

 

236

 

199

 

18

%

17

%

SIMPONI

 

233

 

199

 

17

%

9

%

PNEUMOVAX 23

 

193

 

166

 

16

%

15

%

Animal Health

 

1,090

 

955

 

14

%

12

%

Livestock

 

633

 

582

 

9

%

7

%

Companion Animals

 

457

 

373

 

23

%

19

%

Other Revenues

 

93

 

216

 

-57

%

-7

%

 

Pharmaceutical Revenue

 

Second-quarter pharmaceutical sales increased 6 percent to $9.3 billion, including a 3 percent positive impact from foreign exchange. The increase was primarily driven by growth in oncology, vaccines 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 $44 million related to Lynparza and $35 million related to Lenvima, which represents Merck’s share of profits from product sales, net of cost of sales and commercialization costs.

 

Growth in vaccines was primarily driven by higher sales of GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] and GARDASIL 9, vaccines to prevent certain cancers and other diseases caused by HPV, reflecting growth in Asia Pacific, primarily due to the ongoing commercial launch in China, and growth in Europe, partially offset by lower sales in the United States 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.

 

Page 6



 

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.

 

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 U.S. market exclusivity for ZETIA (ezetimibe) in late 2016 and VYTORIN (ezetimibe/simvastatin) in April 2017, 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 $1.1 billion for the second quarter of 2018, an increase of 14 percent compared with the second quarter of 2017, including a 2 percent positive impact from foreign exchange. Growth was driven by higher sales of companion animal products, primarily from the BRAVECTO (fluralaner) line of products that kill fleas and ticks in dogs and cats for up to 12 weeks, due in part to a delayed flea and tick season and the timing of customer purchases. Growth was also driven by livestock products, including poultry, ruminants and swine products.

 

Animal Health segment profits were $450 million in the second quarter of 2018, an increase of 14 percent compared with $395 million in the second quarter of 2017.3

 


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.

 

Page 7



 

Second-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

 

Second-Quarter 2018

 

 

 

 

 

 

 

 

 

 

 

Materials and production

 

$3,417

 

$733

 

$3

 

$—

 

$2,681

 

Marketing and administrative

 

2,508

 

16

 

1

 

 

2,491

 

Research and development

 

2,274

 

1

 

3

 

344

 

1,926

 

Restructuring costs

 

228

 

 

228

 

 

 

Other (income) expense, net

 

(48

)

105

 

 

(32

)

(121

)

 

 

 

 

 

 

 

 

 

 

 

 

Second-Quarter 20175

 

 

 

 

 

 

 

 

 

 

 

Materials and production

 

$3,116

 

$827

 

$33

 

$—

 

$2,256

 

Marketing and administrative

 

2,500

 

9

 

2

 

 

2,489

 

Research and development

 

1,782

 

7

 

9

 

 

1,766

 

Restructuring costs

 

166

 

 

166

 

 

 

Other (income) expense, net

 

(73

)

39

 

 

 

(112

)

 

GAAP Expense, EPS and Related Information

 

Gross margin was 67.3 percent for the second quarter of 2018 compared to 68.6 percent for the second quarter of 2017. The decrease in gross margin for the second quarter of 2018 was primarily driven by the amortization of amounts capitalized for potential future milestone payments related to collaborations, the amortization of unfavorable manufacturing variances, in part resulting from the June 2017 cyber-attack, as well as the unfavorable effects of foreign exchange. The decrease was partially offset by a lower net impact of acquisition- and divestiture-related costs and restructuring costs, which reduced gross margin by 7.1 percentage points in the second quarter of 2018 compared with 8.7 percentage points in the second quarter of 2017.

 

Marketing and administrative expenses were $2.5 billion in the second quarter of 2018, comparable to the second quarter of 2017, reflecting the unfavorable effects of foreign exchange and higher administrative costs, offset by lower promotion and direct selling costs.

 

Research and development (R&D) expenses were $2.3 billion in the second quarter of 2018 compared with $1.8 billion in the second quarter of 2017. The increase was driven primarily by a $344 million charge for the Viralytics Limited (Viralytics) acquisition, increased

 


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.

 

Page 8



 

clinical development spending, in particular from oncology collaborations, as well as investment in early drug development.

 

GAAP EPS was $0.63 for the second quarter of 2018 compared with $0.71 for the second quarter of 2017.

 

Non-GAAP Expense, EPS and Related Information

 

The non-GAAP gross margin was 74.4 percent for the second quarter of 2018 compared to 77.3 percent for the second quarter of 2017. The decrease in non-GAAP gross margin was predominantly due to the amortization of amounts capitalized for potential future milestone payments related to collaborations, 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 second quarter of 2018, comparable to the second quarter of 2017, reflecting the unfavorable effects of foreign exchange and higher administrative costs, offset by lower promotion and direct selling costs.

 

Non-GAAP R&D expenses were $1.9 billion in the second quarter of 2018, a 9 percent increase compared to the second quarter of 2017. The increase primarily reflects higher clinical development spending, in particular from oncology collaborations, as well as investment in early drug development.

 

Non-GAAP EPS was $1.06 for the second quarter of 2018 compared with $1.01 for the second quarter of 2017.

 

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

 

Page 9



 

 

 

Second Quarter

 

$ in millions, except EPS amounts

 

2018

 

2017

 

EPS

 

 

 

 

 

GAAP EPS

 

$0.63

 

$0.71

 

Difference6

 

0.43

 

0.30

 

Non-GAAP EPS that excludes items listed below2

 

$1.06

 

$1.01

 

 

 

 

 

 

 

Net Income

 

 

 

 

 

GAAP net income1

 

$1,707

 

$1,946

 

Difference

 

1,147

 

832

 

Non-GAAP net income that excludes items listed below1,2

 

$2,854

 

$2,778

 

 

 

 

 

 

 

Decrease (Increase) in Net Income Due to Excluded Items:

 

 

 

 

 

Acquisition- and divestiture-related costs4

 

$855

 

$882

 

Restructuring costs

 

235

 

210

 

Charge for Viralytics acquisition

 

344

 

 

Other

 

(32

)

 

Net decrease (increase) in income before taxes

 

1,402

 

1,092

 

Estimated income tax (benefit) expense

 

(255

)

(260

)

Decrease (increase) in net income

 

$1,147

 

$832

 

 

Financial Outlook

 

Merck narrowed its full-year 2018 revenue range to be between $42.0 billion and $42.8 billion, including a slightly positive impact from foreign exchange at current exchange rates.

 

Merck narrowed and raised its full-year 2018 GAAP EPS range to be between $2.51 and $2.59. Merck narrowed and raised its full-year 2018 non-GAAP EPS range to be between $4.22 and $4.30. Both include 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, and certain other items.

 

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

 

 

 

GAAP

 

Non-GAAP2

 

 

 

 

 

Revenue

 

$42.0 to $42.8 billion

 

$42.0 to $42.8 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

 

23.0% to 24.0%

 

18.5% to 19.5%

EPS**

 

$2.51 to $2.59

 

$4.22 to $4.30

 

*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.

 


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.

 

Page 10



 

$ in millions, except EPS amounts

 

Full-Year 2018

 

 

 

 

 

GAAP EPS

 

$2.51 to $2.59

 

Difference6

 

1.71

 

Non-GAAP EPS that excludes items listed below2

 

$4.22 to $4.30

 

 

 

 

 

Acquisition- and divestiture-related costs4

 

$2,850

 

Restructuring costs

 

500

 

Aggregate charge related to the formation of a collaboration with Eisai

 

1,400

 

Charge for Viralytics acquisition

 

344

 

Net decrease (increase) in income before taxes

 

5,094

 

Estimated income tax (benefit) expense

 

(515

)

Decrease (increase) in net income

 

$4,579

 

 

The expected full-year 2018 GAAP effective tax rate of 23.0 percent to 24.0 percent reflects an unfavorable impact of approximately 4.5 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 6985606. Members of the media are invited to monitor the call by dialing (706) 758-9928 or (800) 399-7917 and using ID code number 6985606. 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.

 

Page 11



 

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

 

 

 

GAAP

 

 

 

 

 

2Q18

 

2Q17

 

% Change

 

June YTD
2018

 

June YTD
2017

 

% Change

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sales

 

$

10,465

 

$

9,930

 

5

%

$

20,502

 

$

19,365

 

6

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Costs, Expenses and Other

 

 

 

 

 

 

 

 

 

 

 

 

 

Materials and production (1)

 

3,417

 

3,116

 

10

%

6,601

 

6,165

 

7

%

Marketing and administrative (1) 

 

2,508

 

2,500

 

 

5,016

 

4,972

 

1

%

Research and development (1) (2)

 

2,274

 

1,782

 

28

%

5,470

 

3,612

 

51

%

Restructuring costs (3) 

 

228

 

166

 

37

%

323

 

317

 

2

%

Other (income) expense, net (1)

 

(48

)

(73

)

-34

%

(340

)

(143

)

*

 

Income Before Taxes

 

2,086

 

2,439

 

-14

%

3,432

 

4,442

 

-23

%

Taxes on Income (1)

 

370

 

488

 

-24

%

975

 

935

 

4

%

Net Income

 

1,716

 

1,951

 

-12

%

2,457

 

3,507

 

-30

%

Less: Net Income Attributable to Noncontrolling Interests

 

9

 

5

 

 

 

14

 

11

 

 

 

Net Income Attributable to Merck & Co., Inc.

 

$

1,707

 

$

1,946

 

-12

%

$

2,443

 

$

3,496

 

-30

%

Earnings per Common Share Assuming Dilution

 

$

0.63

 

$

0.71

 

-11

%

$

0.90

 

$

1.27

 

-29

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Average Shares Outstanding Assuming Dilution

 

2,696

 

2,752

 

 

 

2,702

 

2,759

 

 

 

Tax Rate (4)

 

17.8

%

20.0

%

 

 

28.4

%

21.0

%

 

 

 


* 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 second quarter and first six months of 2018 include a $344 million charge for the acquisition of Viralytics Limited. Research and development expenses in the first six months of 2018 also 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 six months 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

SECOND 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

 

$

3,417

 

733

 

3

 

 

 

736

 

$

2,681

 

Marketing and administrative

 

2,508

 

16

 

1

 

 

 

17

 

2,491

 

Research and development

 

2,274

 

1

 

3

 

344

 

348

 

1,926

 

Restructuring costs

 

228

 

 

 

228

 

 

 

228

 

 

Other (income) expense, net

 

(48

)

105

 

 

 

(32

)

73

 

(121

)

Income Before Taxes

 

2,086

 

(855

)

(235

)

(312

)

(1,402

)

3,488

 

Income Tax Provision (Benefit)

 

370

 

(113

)(4)

(28

)(4)

(114

)(4)

(255

)

625

 

Net Income

 

1,716

 

(742

)

(207

)

(198

)

(1,147

)

2,863

 

Net Income Attributable to Merck & Co., Inc.

 

1,707

 

(742

)

(207

)

(198

)

(1,147

)

2,854

 

Earnings per Common Share Assuming Dilution

 

$

0.63

 

(0.28

)

(0.08

)

(0.07

)

(0.43

)

$

1.06

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Tax Rate

 

17.8

%

 

 

 

 

 

 

 

 

17.9

%

 

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 reflect an increase in the estimated fair value measurement of liabilities for contingent consideration.  Amounts included in other (income) expense, net 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 research and development expenses represents a 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.

GAAP TO NON-GAAP RECONCILIATION

SIX MONTHS ENDED JUNE 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

 

$

6,601

 

1,467

 

9

 

 

 

1,476

 

$

5,125

 

Marketing and administrative

 

5,016

 

24

 

2

 

 

 

26

 

4,990

 

Research and development

 

5,470

 

2

 

5

 

1,744

 

1,751

 

3,719

 

Restructuring costs

 

323

 

 

 

323

 

 

 

323

 

 

Other (income) expense, net

 

(340

)

95

 

 

 

(54

)

41

 

(381

)

Income Before Taxes

 

3,432

 

(1,588

)

(339

)

(1,690

)

(3,617

)

7,049

 

Income Tax Provision (Benefit)

 

975

 

(204

)(4)

(49

)(4)

(109

)(4)

(362

)

1,337

 

Net Income

 

2,457

 

(1,384

)

(290

)

(1,581

)

(3,255

)

5,712

 

Net Income Attributable to Merck & Co., Inc.

 

2,443

 

(1,384

)

(290

)

(1,581

)

(3,255

)

5,698

 

Earnings per Common Share Assuming Dilution

 

$

0.90

 

(0.51

)

(0.11

)

(0.59

)

(1.21

)

$

2.11

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Tax Rate

 

28.4

%

 

 

 

 

 

 

 

 

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 reflect an increase in the estimated fair value measurement of liabilities for contingent consideration.  Amounts included in other (income) expense, net 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) 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

 

2Q

 

June YTD

 

 

 

 

 

 

 

June

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1Q

 

2Q

 

YTD

 

1Q

 

2Q

 

June YTD

 

3Q

 

4Q

 

Full Year

 

Nom %

 

Ex-Exch %

 

Nom %

 

Ex-Exch %

 

TOTAL SALES (1)

 

$

10,037

 

$

10,465

 

$

20,502

 

$

9,434

 

$

9,930

 

$

19,365

 

$

10,325

 

$

10,433

 

$

40,122

 

5

 

4

 

6

 

4

 

PHARMACEUTICAL

 

8,919

 

9,282

 

18,201

 

8,185

 

8,759

 

16,944

 

9,156

 

9,290

 

35,390

 

6

 

3

 

7

 

3

 

Oncology

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Keytruda

 

1,464

 

1,667

 

3,131

 

584

 

881

 

1,465

 

1,047

 

1,297

 

3,809

 

89

 

86

 

114

 

108

 

Emend

 

125

 

148

 

273

 

133

 

143

 

276

 

137

 

143

 

556

 

3

 

1

 

-1

 

-4

 

Temodar

 

57

 

56

 

113

 

66

 

65

 

130

 

68

 

73

 

271

 

-13

 

-16

 

-13

 

-17

 

Alliance Revenue — Lynparza

 

33

 

44

 

76

 

 

 

 

 

 

 

5

 

16

 

20

 

 

 

 

 

 

 

 

 

Alliance Revenue — Lenvima

 

 

 

35

 

35

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Vaccines (2)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Gardasil / Gardasil 9

 

660

 

608

 

1,269

 

532

 

469

 

1,001

 

675

 

633

 

2,308

 

30

 

26

 

27

 

23

 

ProQuad / M-M-R II / Varivax

 

392

 

426

 

818

 

355

 

399

 

754

 

519

 

403

 

1,676

 

7

 

6

 

8

 

7

 

Pneumovax 23

 

179

 

193

 

372

 

163

 

166

 

329

 

229

 

263

 

821

 

16

 

15

 

13

 

11

 

RotaTeq

 

193

 

156

 

349

 

224

 

123

 

347

 

179

 

160

 

686

 

27

 

26

 

1

 

-1

 

Zostavax

 

65

 

44

 

108

 

154

 

160

 

313

 

234

 

121

 

668

 

-73

 

-74

 

-65

 

-67

 

Hospital Acute Care

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Bridion

 

204

 

240

 

444

 

148

 

163

 

310

 

185

 

209

 

704

 

48

 

45

 

43

 

38

 

Noxafil

 

176

 

188

 

363

 

141

 

155

 

296

 

162

 

179

 

636

 

21

 

17

 

23

 

17

 

Invanz

 

151

 

149

 

300

 

136

 

150

 

286

 

159

 

157

 

602

 

-1

 

-1

 

5

 

3

 

Cubicin

 

98

 

94

 

192

 

96

 

103

 

198

 

91

 

92

 

382

 

-9

 

-11

 

-3

 

-7

 

Cancidas

 

91

 

87

 

178

 

121

 

112

 

233

 

94

 

95

 

422

 

-23

 

-27

 

-24

 

-29

 

Primaxin

 

72

 

68

 

140

 

62

 

71

 

133

 

73

 

74

 

280

 

-4

 

-11

 

5

 

-2

 

Immunology

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Simponi

 

231

 

233

 

464

 

184

 

199

 

383

 

219

 

217

 

819

 

17

 

9

 

21

 

10

 

Remicade

 

167

 

157

 

324

 

229

 

208

 

437

 

214

 

186

 

837

 

-24

 

-29

 

-26

 

-33

 

Neuroscience

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Belsomra

 

54

 

71

 

125

 

42

 

52

 

94

 

56

 

60

 

210

 

35

 

33

 

33

 

30

 

Virology

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Isentress / Isentress HD

 

281

 

305

 

586

 

305

 

282

 

587

 

310

 

308

 

1,204

 

8

 

6

 

0

 

-3

 

Zepatier

 

131

 

113

 

243

 

378

 

517

 

895

 

468

 

296

 

1,660

 

-78

 

-80

 

-73

 

-75

 

Cardiovascular

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Zetia

 

305

 

226

 

531

 

334

 

367

 

701

 

320

 

323

 

1,344

 

-39

 

-42

 

-24

 

-30

 

Vytorin

 

167

 

155

 

322

 

241

 

182

 

423

 

142

 

186

 

751

 

-15

 

-20

 

-24

 

-30

 

Atozet

 

73

 

101

 

174

 

49

 

63

 

112

 

59

 

54

 

225

 

62

 

51

 

55

 

42

 

Adempas

 

68

 

75

 

143

 

84

 

67

 

151

 

70

 

79

 

300

 

13

 

8

 

-5

 

-11

 

Diabetes (3)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Januvia

 

880

 

949

 

1,829

 

839

 

948

 

1,787

 

1,012

 

938

 

3,737

 

0

 

-2

 

2

 

0

 

Janumet

 

544

 

585

 

1,129

 

496

 

563

 

1,059

 

513

 

586

 

2,158

 

4

 

1

 

7

 

3

 

Women’s Health

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NuvaRing

 

216

 

236

 

452

 

160

 

199

 

359

 

214

 

188

 

761

 

18

 

17

 

26

 

24

 

Implanon / Nexplanon

 

174

 

174

 

348

 

170

 

178

 

349

 

155

 

183

 

686

 

-3

 

-3

 

0

 

-1

 

Diversified Brands

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Singulair

 

175

 

185

 

360

 

186

 

203

 

389

 

161

 

182

 

732

 

-9

 

-13

 

-7

 

-13

 

Cozaar / Hyzaar

 

120

 

125

 

245

 

112

 

119

 

231

 

128

 

125

 

484

 

5

 

1

 

6

 

1

 

Nasonex

 

122

 

81

 

203

 

139

 

85

 

224

 

42

 

120

 

387

 

-5

 

-7

 

-9

 

-13

 

Arcoxia

 

83

 

84

 

166

 

103

 

89

 

192

 

80

 

91

 

363

 

-6

 

-8

 

-13

 

-17

 

Follistim AQ

 

67

 

70

 

138

 

81

 

79

 

160

 

72

 

66

 

298

 

-11

 

-14

 

-14

 

-18

 

Fosamax

 

55

 

59

 

114

 

61

 

66

 

127

 

53

 

62

 

241

 

-11

 

-15

 

-10

 

-16

 

Dulera

 

57

 

42

 

99

 

82

 

69

 

151

 

59

 

77

 

287

 

-39

 

-40

 

-35

 

-35

 

Other Pharmaceutical (4)

 

989

 

1,053

 

2,045

 

995

 

1,064

 

2,062

 

952

 

1,048

 

4,065

 

-1

 

0

 

-1

 

-5

 

ANIMAL HEALTH

 

1,065

 

1,090

 

2,155

 

939

 

955

 

1,894

 

1,000

 

981

 

3,875

 

14

 

12

 

14

 

9

 

Livestock

 

652

 

633

 

1,286

 

578

 

582

 

1,161

 

647

 

668

 

2,476

 

9

 

7

 

11

 

7

 

Companion Animals

 

413

 

457

 

869

 

361

 

373

 

733

 

353

 

313

 

1,399

 

23

 

19

 

18

 

14

 

Other Revenues (5)

 

53

 

93

 

146

 

310

 

216

 

527

 

169

 

162

 

857

 

-57

 

-7

 

-72

 

-14

 

 

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 and $1,533 million in the first and second 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 and $1,571 million in the first and second 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.