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Merck Announces Third-Quarter 2019 Financial Results

October 29, 2019 6:45 AM

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 2019.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20191029005380/en/

“We achieved another quarter of strong revenue and earnings growth as we continue to realize the benefits of our sustained investment in research and development and our focus on commercial execution,” said Kenneth C. Frazier, chairman and chief executive officer, Merck. “We are confident that the investments we are making now will allow us to convert cutting-edge science into medicines and vaccines of great benefit to patients and value to shareholders.”

Financial Summary

$ in millions, except EPS amounts

Third Quarter

2019

2018

Change

Change
Ex-
Exchange

Sales

$12,397

$10,794

15%

16%

GAAP net income1

1,901

1,950

-3%

-3%

Non-GAAP net income that excludes certain items1,2*

3,873

3,178

22%

22%

GAAP EPS

0.74

0.73

1%

1%

Non-GAAP EPS that excludes certain items2*

1.51

1.19

27%

27%

*Refer to table on page 9

GAAP (generally accepted accounting principles) earnings per share assuming dilution (EPS) were $0.74 for the third quarter of 2019. Non-GAAP EPS of $1.51 for the third quarter of 2019 excludes a $982 million charge for the acquisition of Peloton Therapeutics, Inc. (Peloton), a $612 million pretax intangible asset impairment charge, other acquisition- and divestiture-related costs, restructuring costs and certain other items. Year-to-date results can be found in the attached tables.

Pipeline Highlights

Oncology

Merck continued to advance 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

Lynparza

Lenvima

Other Pipeline Highlights

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

2019

2018

Change

Change Ex-
Exchange

Total Sales

$12,397

$10,794

15%

16%

Pharmaceutical

11,095

9,658

15%

16%

KEYTRUDA

3,070

1,889

62%

64%

GARDASIL / GARDASIL 9

1,320

1,048

26%

27%

JANUVIA / JANUMET

1,311

1,490

-12%

-11%

PROQUAD, M-M-R II and

VARIVAX

623

525

19%

19%

BRIDION

284

217

31%

32%

ISENTRESS / ISENTRESS HD

250

275

-9%

-6%

NUVARING

241

234

3%

4%

PNEUMOVAX 23

237

214

11%

11%

SIMPONI

203

210

-3%

1%

IMPLANON / NEXPLANON

199

186

7%

8%

Animal Health

1,122

1,021

10%

12%

Livestock

726

660

10%

12%

Companion Animals

396

361

10%

12%

Other Revenues

180

115

59%

-18%

Pharmaceutical Revenue

Third-quarter pharmaceutical sales were $11.1 billion, an increase of 15% compared with the third quarter of 2018; excluding the unfavorable effect of foreign exchange, sales grew 16% in the third quarter. The increase was driven primarily by growth in oncology and vaccines, partially offset by the ongoing impacts of the loss of market exclusivity for several products as well as lower sales of JANUVIA (sitagliptin) and JANUMET (sitagliptin and metformin HCI). International pharmaceutical sales represented 54% of total sales in the quarter. Performance in international markets was led by China, which had pharmaceutical sales of $898 million representing growth of 84% compared with the third quarter of 2018, driven by vaccines, primarily GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] and GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant), and oncology. Excluding the unfavorable effect of foreign exchange, pharmaceutical sales in China grew by 90%.

Growth in oncology was largely driven by a $1.2 billion increase in sales for KEYTRUDA to $3.1 billion, reflecting strong momentum from the NSCLC indications as well as continued uptake in other indications, including the recently launched RCC and adjuvant melanoma indications, along with growth from Lynparza and Lenvima.

Growth in vaccines reflects higher sales of GARDASIL and GARDASIL 9, vaccines to prevent certain cancers and other diseases caused by HPV, primarily due to higher demand in Asia Pacific, particularly in China. Also contributing to sales growth was higher demand in Europe, driven primarily by increased vaccination rates for both boys and girls, as well as higher pricing and demand in the United States, partially offset by public sector buying patterns.

In October 2019, the company borrowed doses of GARDASIL 9 from the U.S. Centers for Disease and Control and Prevention’s (CDC) Pediatric Vaccine Stockpile, which will reduce GARDASIL 9 sales in the fourth quarter of 2019 by approximately $120 million. These doses will be allocated to support routine vaccination in the United States and will allow the company to manufacture doses for other parts of the world, including regions where some of the most vulnerable populations live.

Growth in pediatric vaccines was driven by VARIVAX (Varicella Virus Vaccine Live), a vaccine to help prevent chickenpox, and PROQUAD (Measles, Mumps, Rubella and Varicella Virus Vaccine Live), a combination vaccine to help protect against measles, mumps, rubella and varicella, reflecting higher demand and pricing in the United States and higher demand in Europe and Latin America.

Performance in hospital acute care reflects higher demand globally, particularly 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 the ongoing launch of PREVYMIS (letermovir), a medicine for prophylaxis (prevention) of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant.

Pharmaceutical sales growth for the quarter was partially offset by the ongoing impacts from the loss of market exclusivity for INVANZ (ertapenem sodium), ZETIA (ezetimibe) and VYTORIN (ezetimibe/simvastatin), CUBICIN (daptomycin) and REMICADE (infliximab). In addition, the decline in sales of JANUVIA and JANUMET reflects continued pricing pressure in the United States, which more than offset higher demand globally.

Animal Health Revenue

Animal Health sales totaled $1.1 billion for the third quarter of 2019, an increase of 10% compared with the third quarter of 2018. Excluding the unfavorable effect from foreign exchange, Animal Health sales grew 12%. Growth in the third quarter was primarily driven by livestock, due to products acquired in the Antelliq acquisition, along with growth from companion animal products, driven largely by higher sales of the BRAVECTO (fluralaner) line of products for parasitic control.

Animal Health segment profits were $423 million in the third quarter of 2019, an increase of 4% compared with $409 million in the third quarter of 2018.3

Third-Quarter Expense, EPS and Related Information

The tables below present selected expense information.

$ in millions


Third-Quarter 2019

GAAP

Acquisition- and
Divestiture-
Related Costs
4

Restructuring
Costs

Certain Other
Items

Non-GAAP2

Cost of sales

$3,990

$941

$62

$−

$2,987

Selling, general and administrative

2,589

22

1

2,566

Research and development

3,204

6

1

982

2,215

Restructuring costs

232

232

Other (income) expense, net

35

6

29

Third-Quarter 2018

Cost of sales

$3,619

$680

$2

$420

$2,517

Selling, general 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)

GAAP Expense, EPS and Related Information

Gross margin was 67.8% for the third quarter of 2019 compared to 66.5% for the third quarter of 2018. The increase in gross margin for the third quarter of 2019 reflects the favorable impacts of a charge in 2018 related to the termination of a collaboration agreement with Samsung Bioepis Co., Ltd. and product mix, partially offset by higher acquisition- and divestiture-related costs, including the impact of a 2019 intangible asset impairment charge, higher amortization of unfavorable manufacturing variances, higher amortization of intangible assets related to collaborations, higher restructuring costs, as well as manufacturing facilities startup costs.

Selling, general and administrative expenses were $2.6 billion in the third quarter of 2019, a 6% increase compared to the third quarter of 2018. The increase primarily reflects higher promotion and administrative costs primarily in support of strategic brands, and higher acquisition- and divestiture-related costs, partially offset by the favorable effects of foreign exchange.

Research and development (R&D) expenses were $3.2 billion in the third quarter of 2019, an increase of 55% compared with the third quarter of 2018. The increase was driven primarily by a $982 million charge recorded in the third quarter of 2019 for the acquisition of Peloton coupled with higher expenses related to clinical development and increased investment in discovery research and early drug development.

Other (income) expense, net, was $35 million of expense in the third quarter of 2019 compared to $172 million of income in the third quarter of 2018 primarily reflecting lower income from investments in equity securities and higher net interest expense.

The effective income tax rate of 18.7% for the third quarter of 2019 includes the unfavorable impact of the charge for the acquisition of Peloton for which no tax benefit was recognized and the favorable impact of product mix.

GAAP EPS was $0.74 for the third quarter of 2019 compared with $0.73 for the third quarter of 2018.

Non-GAAP Expense, EPS and Related Information

The non-GAAP gross margin was 75.9% for the third quarter of 2019 compared to 76.7% for the third quarter of 2018. The decrease in non-GAAP gross margin primarily reflects higher amortization of unfavorable manufacturing variances, higher amortization of intangible assets related to collaborations, as well as manufacturing facilities startup costs.

Non-GAAP selling, general and administrative expenses were $2.6 billion in the third quarter of 2019, a 5% increase compared to the third quarter of 2018. The increase reflects higher promotion and administrative costs primarily in support of strategic brands, partially offset by the favorable effects of foreign exchange.

Non-GAAP R&D expenses were $2.2 billion in the third quarter of 2019, a 7% increase compared to the third quarter of 2018. The increase primarily reflects higher expenses related to clinical development and increased investment in discovery research and early drug development.

Non-GAAP other (income) expense, net, was $29 million of expense in the third quarter of 2019 compared to $162 million of income in the third quarter of 2018 primarily reflecting lower income from investments in equity securities and higher net interest expense.

The non-GAAP effective income tax rate of 15.7% for the third quarter of 2019 reflects the favorable impact of product mix.

Non-GAAP EPS was $1.51 for the third quarter of 2019 compared with $1.19 for the third quarter of 2018.

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

2019

2018

EPS

GAAP EPS

$0.74

$0.73

Difference5

0.77

0.46

Non-GAAP EPS that excludes items listed below2

$1.51

$1.19

Net Income

GAAP net income1

$1,901

$1,950

Difference

1,972

1,228

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

$3,873

$3,178

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

Acquisition- and divestiture-related costs4

$975

$677

Restructuring costs

296

169

Charge for the acquisition of Peloton

982

Charge related to the termination of a collaboration agreement with Samsung

420

Net decrease (increase) in income before taxes

2,253

1,266

Estimated income tax (benefit) expense

(281)

(38)

Decrease (increase) in net income

$1,972

$1,228

Financial Outlook

Merck narrowed and raised its full-year 2019 revenue range to be between $46.5 billion and $47.0 billion, including both the impact of the GARDASIL 9 stockpile borrowing noted above and a negative impact from foreign exchange of approximately 2% at mid-October exchange rates.

Merck reduced its expected full-year GAAP effective tax rate to approximately 16.5% and its expected full-year non-GAAP effective tax rate to approximately 17.5%. These reductions are primarily attributable to favorable product mix.

Merck narrowed and reduced its full-year 2019 GAAP EPS range to be between $3.75 and $3.80. The change in the GAAP EPS range primarily reflects the impact of the intangible asset impairment charge noted above. Merck narrowed and raised its full-year 2019 non-GAAP EPS range to be between $5.12 and $5.17, including a negative impact from foreign exchange of approximately 1% at mid-October exchange rates. The non-GAAP range excludes acquisition- and divestiture-related costs, costs related to restructuring programs, a net benefit from the settlement of certain federal income tax matters, the charge for the acquisition of Peloton and certain other items.

The following table summarizes the company’s full-year 2019 financial guidance.

GAAP

Non-GAAP2

Revenue

$46.5 to $47.0 billion

$46.5 to $47.0 billion*

Operating expenses

Higher than 2018 by a low-single digit rate

Higher than 2018 by a mid-single digit rate

Effective tax rate

Approximately 16.5%

Approximately 17.5%

EPS**

$3.75 to $3.80

$5.12 to $5.17

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

**EPS guidance for 2019 assumes a share count (assuming dilution) of approximately 2.6 billion shares.

A reconciliation of anticipated 2019 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 2019

GAAP EPS

$3.75 to $3.80

Difference5

1.37

Non-GAAP EPS that excludes items listed below2

$5.12 to $5.17

Acquisition- and divestiture-related costs4

$2,700

Restructuring costs

Charge for the acquisition of Peloton

750

982

Net decrease (increase) in income before taxes

4,432

Income tax (benefit) expense6

(900)

Decrease (increase) in net income

$3,532

The expected full-year GAAP effective tax rate of 16.5% reflects a net favorable impact of approximately one percentage point 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 5635157. Members of the media are invited to monitor the call by dialing (706) 758-9928 or (800) 399-7917 and using ID code number 5635157. Journalists who wish to ask questions are requested to contact a member of Merck’s Media Relations team at the conclusion of the call.

About Merck

For more than a century, Merck, a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world - including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease and infectious diseases including HIV and Ebola. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2018 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

_________________________

1

Net income attributable to Merck & Co., Inc.

2

Merck is providing certain 2019 and 2018 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 and 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 cost of sales, as well as selling, general 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 liabilities for contingent consideration. Also includes integration, transaction and certain other costs related to business acquisitions and divestitures.

5

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.

6

Includes the estimated tax impact on the reconciling items. In addition, includes a $360 million net tax benefit related to the settlement of certain federal income tax matters and a $67 million tax charge related to the finalization of treasury regulations for the Tax Cuts and Jobs Act of 2017.

MERCK & CO., INC.
CONSOLIDATED STATEMENT OF INCOME - GAAP
(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)
(UNAUDITED)
Table 1
GAAP % Change GAAP % Change
3Q19 3Q18 Sep YTD
2019
Sep YTD
2018
Sales

$

12,397

$

10,794

15%

$

34,972

$

31,296

12%

Costs, Expenses and Other

Cost of sales (1)

3,990

3,619

10%

10,443

10,220

2%

Selling, general and administrative (1)

2,589

2,443

6%

7,726

7,459

4%

Research and development (1)(2)

3,204

2,068

55%

7,324

7,538

-3%

Restructuring costs (3)

232

171

36%

444

494

-10%

Other (income) expense, net (1)

35

(172

)

*

362

(512

)

*

Income Before Taxes

2,347

2,665

-12%

8,673

6,097

42%

Taxes on Income (1)

440

707

1,259

1,682

Net Income

1,907

1,958

-3%

7,414

4,415

68%

Less: Net Income (Loss) Attributable to Noncontrolling Interests (1)

6

8

(73

)

22

Net Income Attributable to Merck & Co., Inc.

$

1,901

$

1,950

-3%

$

7,487

$

4,393

70%

Earnings per Common Share Assuming Dilution

$

0.74

$

0.73

1%

$

2.89

$

1.63

77%

Average Shares Outstanding Assuming Dilution

2,572

2,678

2,587

2,694

Tax Rate (4)

18.7

%

26.5

%

14.5

%

27.6

%

* 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 for the third quarter and first nine months of 2019 include a $982 million charge for the acquisition of Peloton Therapeutics (Peloton). Research and development expenses in the first nine months of 2018 include a $344 million charge for the acquisition of Viralytics Limited. Research and development expenses in the first nine months of 2018 also include a $1.4 billion 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 rates for the third quarter and the first nine months of 2019 include the unfavorable impact of a charge for the acquisition of Peloton for which no tax benefit was recognized and the favorable impact of product mix. The effective income tax rate for the first nine months of 2019 reflects a net tax benefit of $360 million related to the settlement of certain federal income tax matters. The effective income tax rates for the third quarter and first nine months of 2018 include the unfavorable impact of a 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 reflects the unfavorable impact of a 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
THIRD QUARTER 2019
(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)
(UNAUDITED)
Table 2a
GAAP Acquisition and
Divestiture-Related
Costs (1)
Restructuring
Costs (2)
Certain Other
Items (4)
Adjustment
Subtotal
Non-GAAP
Cost of sales

$

3,990

941

62

1,003

$

2,987

Selling, general and administrative

2,589

22

1

23

2,566

Research and development

3,204

6

1

982

989

2,215

Restructuring costs

232

232

232

-

Other (income) expense, net

35

6

6

29

Income Before Taxes

2,347

(975

)

(296

)

(982

)

(2,253

)

4,600

Income Tax Provision (Benefit)

440

(231

)

(3)

(50

)

(3)

-

(281

)

721

Net Income

1,907

(744

)

(246

)

(982

)

(1,972

)

3,879

Net Income Attributable to Merck & Co., Inc.

1,901

(744

)

(246

)

(982

)

(1,972

)

3,873

Earnings per Common Share Assuming Dilution

$

0.74

(0.29

)

(0.10

)

(0.38

)

(0.77

)

$

1.51

Tax Rate

18.7

%

15.7

%

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) Amount included in cost of sales primarily reflects $320 million of expenses for the amortization of intangible assets recognized as a result of business acquisitions, as well as $612 million of intangible asset impairment charges related to SIVEXTRO. Amount included in selling, general and administrative expenses primarily reflects integration, transaction and certain other costs related to business acquisitions and divestitures.
(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) Represents the estimated tax impact on the reconciling items based on applying the statutory rate of the originating territory of the non-GAAP adjustments.
(4) Amount included in research and development represents the charge related to the acquisition of Peloton Therapeutics.
MERCK & CO., INC.
GAAP TO NON-GAAP RECONCILIATION
NINE MONTHS ENDED SEPTEMBER 30, 2019
(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)
(UNAUDITED)
Table 2b
GAAP Acquisition and
Divestiture-Related
Costs (1)
Restructuring
Costs (2)
Certain Other
Items (4)
Adjustment
Subtotal
Non-GAAP
Cost of sales

$

10,443

1,801

161

1,962

$

8,481

Selling, general and administrative

7,726

82

33

115

7,611

Research and development

7,324

(21

)

4

982

965

6,359

Restructuring costs

444

444

444

-

Other (income) expense, net

362

321

48

369

(7

)

Income Before Taxes

8,673

(2,183

)

(642

)

(1,030

)

(3,855

)

12,528

Income Tax Provision (Benefit)

1,259

(438

)

(3)

(106

)

(3)

(304

)

(5)

(848

)

2,107

Net Income

7,414

(1,745

)

(536

)

(726

)

(3,007

)

10,421

Less: Net (Loss) Income Attributable to Noncontrolling Interests

(73

)

(89

)

(89

)

16

Net Income Attributable to Merck & Co., Inc.

7,487

(1,656

)

(536

)

(726

)

(2,918

)

10,405

Earnings per Common Share Assuming Dilution

$

2.89

(0.64

)

(0.21

)

(0.28

)

(1.13

)

$

4.02

Tax Rate

14.5

%

16.8

%

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) Amount included in cost of sales primarily reflects $1.1 billion of expenses for the amortization of intangible assets recognized as a result of business acquisitions, as well as $693 million of intangible asset impairment charges, including $612 million related to SIVEXTRO. Amount included in selling, general and administrative expenses primarily reflects integration, transaction and certain other costs related to business acquisitions and divestitures, including costs related to the acquisition of Antelliq Corporation. Amount included in research and development expenses primarily reflects a reduction in expenses related to a decrease in the estimated fair value measurement of liabilities for contingent consideration. Amount included in other (income) expense, net primarily reflects goodwill and intangible asset impairment charges related to certain businesses in the Healthcare Services segment and expenses related to 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) Represents the estimated tax impact on the reconciling items based on applying the statutory rate of the originating territory of the non-GAAP adjustments.
(4) Amount included in research and development represents the charge related to the acquisition of Peloton Therapeutics.
(5) Primarily reflects a $360 million net tax benefit related to the settlement of certain federal income tax matters and a $67 million tax charge related to the finalization of treasury regulations associated with the 2017 enactment of U.S. tax legislation.
MERCK & CO., INC.
FRANCHISE / KEY PRODUCT SALES
(AMOUNTS IN MILLIONS)
(UNAUDITED)
Table 3

2019

2018

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)

$

10,816

$

11,760

$

12,397

$

34,972

$

10,037

$

10,465

$

10,794

$

31,296

$

10,998

$

42,294

15

16

12

14

PHARMACEUTICAL

9,663

10,460

11,095

31,218

8,919

9,282

9,658

27,859

9,830

37,689

15

16

12

15

Oncology

Keytruda

2,269

2,634

3,070

7,973

1,464

1,667

1,889

5,020

2,151

7,171

62

64

59

63

Emend

117

121

98

336

125

148

123

396

126

522

-20

-19

-15

-13

Alliance Revenue – Lynparza (2)

79

111

123

313

33

44

49

125

62

187

154

157

151

156

Alliance Revenue – Lenvima (2)

74

97

109

280

35

43

78

71

149

154

156

*

*

Vaccines (3)

Gardasil / Gardasil 9

838

886

1,320

3,044

660

608

1,048

2,317

835

3,151

26

27

31

34

ProQuad / M-M-R II / Varivax

496

675

623

1,794

392

426

525

1,343

455

1,798

19

19

34

36

Pneumovax 23

185

170

237

592

179

193

214

586

322

907

11

11

1

2

RotaTeq

211

172

180

564

193

156

191

540

188

728

-5

-5

4

6

Vaqta

47

58

62

167

37

65

66

167

72

239

-6

-3

0

3

Hospital Acute Care

Bridion

255

278

284

817

204

240

217

661

256

917

31

32

24

27

Noxafil

190

193

177

560

176

188

188

551

191

742

-6

-4

1

5

Cubicin

88

67

52

207

98

94

95

287

80

367

-45

-44

-28

-25

Primaxin

59

71

77

207

72

68

72

212

53

265

7

10

-2

2

Invanz

72

78

57

206

151

149

137

437

59

496

-58

-57

-53

-50

Cancidas

61

67

62

191

91

87

79

257

69

326

-21

-19

-26

-22

Immunology

Simponi

208

214

203

625

231

233

210

673

220

893

-3

1

-7

-1

Remicade

123

98

101

322

167

157

135

459

123

582

-25

-23

-30

-25

Neuroscience

Belsomra

67

76

80

223

54

71

66

191

69

260

22

19

17

17

Virology

Isentress / Isentress HD

255

247

250

752

281

305

275

860

280

1,140

-9

-6

-13

-7

Zepatier

114

108

83

304

131

113

104

347

108

455

-20

-18

-12

-9

Cardiovascular

Zetia

140

156

147

443

305

226

165

696

162

857

-11

-12

-36

-35

Vytorin

97

76

57

231

167

155

92

414

83

497

-38

-36

-44

-41

Atozet

94

92

97

283

73

101

84

258

89

347

15

19

9

16

Adempas

90

104

107

302

68

75

94

238

91

329

14

15

27

30

Diabetes (4)

Januvia

824

908

807

2,539

880

949

927

2,756

930

3,686

-13

-12

-8

-6

Janumet

530

533

503

1,567

544

585

563

1,693

535

2,228

-11

-9

-7

-4

Women's Health

NuvaRing

219

240

241

700

216

236

234

686

216

902

3

4

2

3

Implanon / Nexplanon

199

183

199

581

174

174

186

535

169

703

7

8

9

10

Diversified Brands

Singulair

191

160

152

503

175

185

161

521

187

708

-6

-5

-3

0

Cozaar / Hyzaar

103

109

116

329

120

125

103

348

105

453

13

16

-6

-1

Nasonex

96

72

58

226

122

81

71

274

102

376

-17

-17

-17

-14

Arcoxia

75

75

72

221

83

84

83

249

86

335

-13

-11

-11

-6

Follistim AQ

57

63

62

182

67

70

60

198

70

268

2

4

-8

-5

Other Pharmaceutical (5)

1,140

1,268

1,229

3,634

1,186

1,189

1,109

3,486

1,215

4,705

11

12

4

8

ANIMAL HEALTH

1,025

1,124

1,122

3,271

1,065

1,090

1,021

3,176

1,036

4,212

10

12

3

8

Livestock

611

671

726

2,007

652

633

660

1,946

684

2,630

10

12

3

9

Companion Animals

414

453

396

1,264

413

457

361

1,230

352

1,582

10

12

3

7

Other Revenues (6)

128

176

180

483

53

93

115

261

132

393

59

-18

86

-54

* 200% or greater
Sum of quarterly amounts may not equal year-to-date amounts due to rounding.
(1) Only select products are shown.
(2) Alliance Revenue represents Merck’s share of profits, which are product sales net of cost of sales and commercialization costs.
(3) Total Vaccines sales were $1,887 million, $2,037 million and $2,517 million in the first, second and third quarters of 2019, respectively, and $1,561 million, $1,533 million, $2,159 million and $2,008 million for the first, second, third and fourth quarters of 2018, respectively.
(4) Total Diabetes sales were $1,402 million, $1,480 million and $1,360 million in the first, second and third quarters of 2019, respectively, and $1,433 million, $1,571 million, $1,506 million and $1,485 million for the first, second, third and fourth quarters of 2018, respectively.
(5) Includes Pharmaceutical products not individually shown above.
(6) Other Revenues are comprised primarily of Healthcare Services segment revenues, third-party manufacturing sales and miscellaneous corporate revenues, including revenue hedging activities.

Media:

Jennifer Mauer

(908) 740-1801

Pamela Eisele

(267) 305-3558

Investors:

Peter Dannenbaum

(908) 740-1037

Michael DeCarbo

(908) 740-1807

Source: Merck

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