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.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the first quarter of 2018.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180501005733/en/

“Merck had a strong start to the year driven by KEYTRUDA, GARDASIL, BRIDION and Animal Health,” said Kenneth C. Frazier, Merck Chairman and CEO. “This provides good momentum as we continue to execute on our pillars of growth and look to deliver innovative medicines and vaccines that address unmet needs for patients around the world.”

Financial Summary

         
        First Quarter
$ in millions, except EPS amounts       2018     2017
Sales       $ 10,037     $ 9,434

GAAP net income1

        736       1,551
Non-GAAP net income that excludes items listed below1,2         2,844       2,437
GAAP EPS         0.27       0.56

Non-GAAP EPS that excludes items listed below2

        1.05       0.88

Worldwide sales were $10.0 billion for the first quarter of 2018, an increase of 6 percent compared with the first quarter of 2017, including a 3 percent positive impact from foreign exchange.

GAAP (generally accepted accounting principles) earnings per share assuming dilution (EPS) were $0.27 for the first quarter of 2018, which reflects a $1.4 billion aggregate charge related to the formation of a collaboration with Eisai Co., Ltd. (Eisai). Non-GAAP EPS of $1.05 for the first quarter of 2018 excludes acquisition- and divestiture-related costs, restructuring costs, the charge related to the Eisai collaboration referenced above and certain other items.

Oncology Pipeline Highlights

Merck expanded its focus in oncology by further advancing the development program for KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy, and Lynparza (olaparib), a PARP inhibitor being co-developed and co-commercialized with AstraZeneca. The company recently presented pivotal Phase 3 data for KEYTRUDA at the American Association for Cancer Research (AACR) Annual Meeting. Additionally, Merck and Eisai entered into a strategic collaboration for the worldwide co-development and co-commercialization of Lenvima (lenvatinib mesylate), an orally available tyrosine kinase inhibitor discovered by Eisai. Eisai and Merck will develop and commercialize Lenvima jointly, both as a monotherapy and in combination with KEYTRUDA.

  • Merck announced results from KEYNOTE-189, a Phase 3 trial evaluating KEYTRUDA in combination with pemetrexed and cisplatin or carboplatin for the first-line treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC). Findings showed that the combination significantly improved overall survival (OS), reducing the risk of death by half compared with chemotherapy alone. In pre-specified exploratory analyses, an OS benefit was observed regardless of PD-L1 expression in the three PD-L1 categories that were evaluated. These results were presented in a plenary session at the AACR Annual Meeting with simultaneous publication in The New England Journal of Medicine (NEJM).
  • Based on the KEYNOTE-189 data, the U.S. Food and Drug Administration (FDA) granted Priority Review for the supplemental Biologics License Application (sBLA) for KEYTRUDA in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous NSCLC with a PDUFA date of Sept. 23, 2018. Additionally, Merck announced that following validation by the European Medicines Agency (EMA), the centralized review process has begun for the company’s Type II Variation, which seeks approval for KEYTRUDA in combination with pemetrexed and platinum cisplatin or carboplatin for the first-line treatment of patients with metastatic nonsquamous NSCLC. The application was accepted for review based on OS and progression-free survival (PFS) data from the Phase 3 KEYNOTE-189 trial.
  • Merck announced the Phase 3 KEYNOTE-042 trial evaluating KEYTRUDA as monotherapy for the first-line treatment of locally advanced or metastatic NSCLC, including nonsquamous or squamous histologies, met its primary endpoint of OS. An interim analysis conducted by the independent Data Monitoring Committee demonstrated that treatment with KEYTRUDA resulted in significantly longer OS than platinum-based chemotherapy (carboplatin plus paclitaxel or carboplatin plus pemetrexed) in patients with a PD-L1 tumor proportion score (TPS) of ≥1 percent.
  • The FDA accepted for review a new sBLA for KEYTRUDA as a treatment in previously treated patients with recurrent or metastatic head and neck squamous cell carcinoma based on data from the Phase 3 KEYNOTE-040 trial. The FDA has set a PDUFA date of Dec. 28, 2018.
  • Merck and the European Organisation for Research and Treatment of Cancer (EORTC), announced findings from the Phase 3 EORTC1325/KEYNOTE-054 trial investigating KEYTRUDA as adjuvant therapy in resected, high-risk stage III melanoma. The results of the study showed KEYTRUDA significantly prolonged recurrence-free survival, reducing the risk of disease recurrence or death by 43 percent compared to placebo in the overall study population. The results were presented in the opening plenary session at the AACR Annual Meeting with simultaneous publication in NEJM.
  • Merck and Incyte Corporation announced that an external Data Monitoring Committee (eDMC) review of the pivotal Phase 3 ECHO-301/KEYNOTE-252 study results evaluating Incyte’s epacadostat in combination with KEYTRUDA in patients with unresectable or metastatic melanoma determined that the study did not meet the primary endpoint of improving PFS in the overall population compared to KEYTRUDA monotherapy. The study’s second primary endpoint of OS also is not expected to reach statistical significance. Based on these results, and at the recommendation of the eDMC, the study will be stopped. The safety profile observed in ECHO-301/KEYNOTE-252 was consistent with that observed in previously reported studies of epacadostat in combination with KEYTRUDA.
  • The FDA accepted a new sBLA and granted Priority Review for KEYTRUDA as a treatment for patients with advanced cervical cancer with disease progression on or after chemotherapy. The FDA has set a PDUFA date of June 28, 2018.
  • The sBLA for KEYTRUDA for the treatment of adult and pediatric patients with refractory primary mediastinal B-cell lymphoma, or who have relapsed after two or more prior lines of therapy, remains under review with the FDA. The FDA has extended the PDUFA date by 90 days to July 3, 2018 due to additional data and analyses submitted by Merck.
  • The Committee for Medicinal Products for Human Use of the EMA adopted a positive opinion, recommending a marketing authorization of Lynparza for use as a maintenance therapy for patients with platinum-sensitive relapsed high grade, epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy.
  • The EMA validated for review the Marketing Authorization Application for Lynparza for use in patients with deleterious or suspected deleterious BRCA-mutated, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. This is the first regulatory submission for a PARP inhibitor in breast cancer in Europe. In January 2018, Lynparza was approved by the FDA for use in the treatment of BRCA-mutated HER2-negative metastatic breast cancer, becoming the first PARP inhibitor to be approved beyond ovarian cancer.
  • The FDA granted Orphan Drug Designation for selumetinib, a MEK 1/2 inhibitor being co-developed with AstraZeneca, for the treatment of neurofibromatosis type 1.
  • Merck and Viralytics Limited signed a definitive agreement under which it is proposed that Merck will acquire Viralytics, an Australian publicly traded company focused on oncolytic immunotherapy treatments for a range of cancers. Upon completion of the transaction, Merck will gain full rights to Cavatak (CVA21), Viralytics’s investigational oncolytic immunotherapy.

Other Pipeline Highlights

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

  • Merck announced the beginning of two Phase 3 studies of V114, an investigational polyvalent conjugate vaccine for the prevention of pneumococcal disease. The first study will evaluate the safety, tolerability and immunogenicity of V114 followed by Pneumococcal Vaccine Polyvalent one year later in healthy adult subjects 50 years of age or older. The second study will evaluate the safety, tolerability and immunogenicity of V114 followed by Pneumococcal Vaccine Polyvalent administered eight weeks later in adults infected with HIV. Results from Phase 1 and Phase 2 studies were presented at the International Society on Pneumococci and Pneumococcal Diseases.
  • Merck presented data from its robust HIV pipeline, including doravirine, a late-stage investigational non-nucleoside reverse transcriptase inhibitor, and MK-8591, an investigational nucleoside reverse transcriptase translocation inhibitor, at the Conference on Retroviruses and Opportunistic Infections. Doravirine is currently under review with the EMA and FDA with a PDUFA date of Oct. 23, 2018 in the United States.
  • Merck announced that a pivotal Phase 3 study of relebactam, the company’s investigational beta-lactamase inhibitor, in combination with imipenem/cilastatin, demonstrated a favorable overall response in the treatment of certain imipenem–non-susceptible bacterial infections, the primary endpoint, with lower treatment-emergent nephrotoxicity (kidney toxicity), a secondary endpoint, compared to a Colistin (colistimethate sodium) plus imipenem regimen. Based on these results, the company plans to submit a New Drug Application to the FDA.

First-Quarter Revenue Performance

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

         
$ in millions       First Quarter
          2018       2017     Change     Change

Ex-Exchange

Total Sales       $ 10,037     $ 9,434     6 %     3 %
Pharmaceutical         8,919       8,185     9 %     4 %
KEYTRUDA         1,464       584     151 %     142 %
JANUVIA / JANUMET         1,424       1,335     7 %     2 %
GARDASIL / GARDASIL 9         660       532     24 %     20 %
ZETIA / VYTORIN         471       575     -18 %     -26 %
PROQUAD,

M-M-R II and VARIVAX

        392       355     10 %     9 %
ISENTRESS / ISENTRESS HD         281       305     -8 %     -12 %
SIMPONI         231       184     26 %     11 %
NUVARING         216       160     36 %     32 %
BRIDION         204       148     38 %     31 %
Animal Health         1,065       939     13 %     7 %
Livestock         652       578     13 %     6 %
Companion Animals         413       361     14 %     9 %
Other Revenues         53       310     -83 %     -19 %

Pharmaceutical Revenue

First-quarter pharmaceutical sales increased 9 percent to $8.9 billion, including a 5 percent positive impact from foreign exchange. The increase was primarily driven by growth in oncology, hospital acute care and diabetes, partially offset by lower sales in virology and the ongoing impacts of the loss of market exclusivity for several products.

Growth in oncology was driven by a significant increase in sales of KEYTRUDA, reflecting the company’s continued launches with new indications globally and the strong momentum for the treatment of patients with NSCLC, as KEYTRUDA is the only anti-PD-1 approved in the first-line setting. Additionally, oncology sales reflect alliance revenue of $33 million related to Lynparza.

Growth in hospital acute care reflects strong global demand of BRIDION (sugammadex) Injection 100 mg/mL, a medicine for the reversal of neuromuscular blockade induced by rocuronium bromide or vecuronium bromide in adults undergoing surgery.

Growth in diabetes was driven by JANUVIA (sitagliptin) and JANUMET (sitagliptin and metformin HCI), medicines that help lower blood sugar in adults with type 2 diabetes, reflecting growth in international markets driven by higher demand, partially offset by pricing pressure. Sales declines in the United States reflect continued pricing pressure that was partially offset by volume growth, as well as a favorable adjustment to rebate reserves.

Performance in vaccines was primarily driven by higher sales of GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] and GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant), vaccines to prevent certain cancers and other diseases caused by HPV, reflecting growth in Asia Pacific, primarily due to the commercial launch in China, and growth in Europe, partially offset by lower sales in the United States. The decrease in GARDASIL/GARDASIL 9 sales in the United States was driven by declining volumes due to the continued transition to the two-dose regimen. Vaccines performance was negatively affected by a significant decrease in sales of ZOSTAVAX (zoster vaccine live), a vaccine for the prevention of herpes zoster, primarily due to the approval of a competitor product that received a preferential recommendation from the U.S. Advisory Committee on Immunization Practices in October 2017. The company anticipates that future sales of ZOSTAVAX will continue to be unfavorably affected by this competition.

Pharmaceutical sales growth in the quarter was partially offset by lower sales in virology, largely reflecting a significant decline in ZEPATIER (elbasvir and grazoprevir), a medicine for the treatment of chronic hepatitis C virus genotypes 1 or 4 infection, due to increasing competition and declining patient volumes, which the company expects to continue.

Pharmaceutical sales growth for the quarter was also partially offset by the ongoing impacts from the loss of United States market exclusivity for ZETIA (ezetimibe) in late 2016 and VYTORIN (ezetimibe/simvastatin) in April 2017, medicines for lowering LDL cholesterol; biosimilar competition for REMICADE (infliximab), a treatment for inflammatory diseases, in the company’s marketing territories in Europe; and the 2017 loss of exclusivity for CANCIDAS (caspofungin acetate for injection), an antifungal, in Europe.

Animal Health

Animal Health sales totaled $1.1 billion for the first quarter of 2018, an increase of 13 percent compared with the first quarter of 2017, including a 6 percent positive impact from foreign exchange. Growth was driven by higher sales of livestock products, primarily ruminants and poultry products, as well as higher sales of companion animal products.

In the first quarter of 2018, Animal Health became a reportable segment, resulting in additional disclosure requirements under U.S. GAAP related to segment performance, including segment profits. Animal Health segment profits were $413 million in the first quarter of 2018, a decrease of 1 percent compared with $417 million in the first quarter of 2017.3

First-Quarter Expense, EPS and Related Information

The table below presents selected expense information.

 
$ in millions

First-Quarter 2018

     

 

GAAP

   

Acquisition- and
Divestiture-
Related Costs4

   

Restructuring
Costs

   

Certain Other
Items

   

 

Non-GAAP2

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 unfavorable effects of foreign exchange and higher administrative costs, reflecting the prioritization of investment in growth products.

Research and development (R&D) expenses were $3.2 billion in the first quarter of 2018 compared with $1.8 billion in the first quarter of 2017. The increase was driven primarily by a $1.4 billion aggregate charge related to the formation of the collaboration with Eisai, the unfavorable effects of foreign exchange, increased clinical development spending and investment in early drug development, partially offset by lower licensing costs.

Other (income) expense, net, was $291 million of income in the first quarter of 2018 compared to $71 million of income in the first quarter of 2017. Other (income) expense, net, in the first quarter of 2018 reflects a gain from a legal settlement and the recognition of unrealized gains on securities as a result of the adoption of a new accounting standard for equity investments.

The effective income tax rate of 44.9 percent for the first quarter of 2018 reflects the unfavorable impact of the $1.4 billion aggregate charge related to the formation of the Eisai collaboration for which no tax benefit has been recognized.

GAAP EPS was $0.27 for the first quarter of 2018 compared with $0.56 for the first quarter of 2017.

Non-GAAP Expense, EPS and Related Information

The non-GAAP gross margin was 75.7 percent for the first quarter of 2018 compared to 77.4 percent for the first quarter of 2017. The decrease in non-GAAP gross margin was predominately due to the amortization of unfavorable manufacturing variances, in part resulting from the June 2017 cyber-attack, as well as the unfavorable effects of foreign exchange.

Non-GAAP marketing and administrative expenses were $2.5 billion in the first quarter of 2018, an increase of 2 percent compared to the first quarter of 2017. The increase in non-GAAP marketing and administrative expenses was driven primarily by the unfavorable effects of foreign exchange and higher administrative costs, reflecting the prioritization of investment in growth products.

Non-GAAP R&D expenses were $1.8 billion in the first quarter of 2018, a 1 percent decrease compared to the first quarter of 2017. The decrease primarily reflects lower licensing costs partially offset by the unfavorable effects of foreign exchange, increased clinical development spending and investment in early drug development.

Non-GAAP other (income) expense, net, was $259 million of income in the first quarter of 2018 compared to $59 million of income in the first quarter of 2017. Non-GAAP other (income) expense, net, in the first quarter of 2018 reflects a gain from a legal settlement and the recognition of unrealized gains on securities as a result of the adoption of a new accounting standard for equity investments.

Non-GAAP EPS was $1.05 for the first quarter of 2018 compared with $0.88 for the first quarter of 2017.

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

         
$ in millions, except EPS amounts       First Quarter
        2018     2017
EPS              
GAAP EPS       $0.27       $0.56  

Difference6

        0.78         0.32  

Non-GAAP EPS that excludes items listed below2

      $1.05       $0.88  
               
Net Income              
GAAP net income1       $736       $1,551  
Difference         2,108         886  
Non-GAAP net income that excludes items listed below1,2       $2,844       $2,437  
               
Decrease (Increase) in Net Income Due to Excluded Items:              
Acquisition- and divestiture-related costs4       $733       $883  
Restructuring costs         104         215  
Aggregate charge related to the formation of a collaboration with Eisai         1,400         --  
Other        

(22)

 

     

(9)

 

Net decrease (increase) in income before taxes         2,215         1,089  
Estimated income tax (benefit) expense        

(107)

 

     

(203)

 

Decrease (increase) in net income       $2,108       $886  

Financial Outlook

Merck has narrowed and raised its full-year 2018 revenue range to be between $41.8 billion and $43.0 billion, including an approximately 2 percent positive impact from foreign exchange at current exchange rates.

Merck has lowered its full-year 2018 GAAP EPS range to be between $2.45 and $2.57. The change in the GAAP EPS range reflects the inclusion of the charge related to the collaboration with Eisai. Merck narrowed and raised its full-year 2018 non-GAAP EPS range to be between $4.16 and $4.28, including an approximately 1 percent positive impact from foreign exchange at current exchange rates. The non-GAAP range excludes acquisition- and divestiture-related costs, costs related to restructuring programs, a charge related to the formation of the collaboration with Eisai and certain other items.

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

                 
        GAAP       Non-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 also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world - including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease and infectious diseases including HIV and Ebola. For more information, visit www.merck.com and connect with us on TwitterFacebookInstagram, YouTube and LinkedIn.

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

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

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

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2017 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

###

1 Net income attributable to Merck & Co., Inc.

2 Merck is providing certain 2018 and 2017 non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing this information enhances investors’ understanding of the company’s results as it permits investors to understand how management assesses performance. Management uses these measures internally for planning and forecasting purposes and to measure the performance of the company along with other metrics. Senior management’s annual compensation is derived in part using non-GAAP income and non-GAAP EPS. This information should be considered in addition to, but not as a substitute for or superior to, information prepared in accordance with GAAP. For a description of the items, see Table 2a attached to this release.

3 Animal Health segment profits are comprised of segment sales, less all materials and production costs, as well as marketing and administrative expenses and research and development costs directly incurred by the segment. For internal management reporting, Merck does not allocate general and administrative expenses not directly incurred by the segment, nor the cost of financing these activities. Separate divisions maintain responsibility for monitoring and managing these costs, including depreciation related to fixed assets utilized by these divisions and, therefore, they are not included in segment profits.

4 Includes expenses for the amortization of intangible assets and purchase accounting adjustments to inventories recognized as a result of acquisitions, intangible asset impairment charges and expense or income related to changes in the estimated fair value measurement of contingent consideration. Also includes integration, transaction and certain other costs related to business acquisitions and divestitures.

5 On Jan. 1, 2018, the company adopted a new accounting standard related to defined benefit plans. Upon adoption, net periodic benefit cost/credit other than service cost was reclassified to Other (income) expense, net from the previous classifications within Materials and production costs, Marketing and administrative expenses and Research and development costs. Previously reported amounts have been reclassified to conform to the new presentation.

6 Represents the difference between calculated GAAP EPS and calculated non-GAAP EPS, which may be different than the amount calculated by dividing the impact of the excluded items by the weighted-average shares for the period.

MERCK & CO., INC.
CONSOLIDATED STATEMENT OF INCOME - GAAP
(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)
(UNAUDITED)
Table 1
       

 

           
        GAAP    

%
Change

        1Q18     1Q17    
                     
Sales       $ 10,037       $ 9,434       6%
                     
Costs, Expenses and Other                    
Materials and production (1)         3,184         3,049       4%
Marketing and administrative (1)         2,508         2,472       1%
Research and development (1) (2)         3,196         1,830       75%
Restructuring costs (3)         95         151       -37%
Other (income) expense, net (1)         (291 )       (71 )     *
Income Before Taxes         1,345         2,003       -33%
Taxes on Income (1)         604         447        
Net Income         741         1,556       -52%
Less: Net Income Attributable to Noncontrolling Interests         5         5        
Net Income Attributable to Merck & Co., Inc.       $ 736       $ 1,551       -53%
Earnings per Common Share Assuming Dilution       $ 0.27       $ 0.56       -52%
                     
Average Shares Outstanding Assuming Dilution         2,710         2,766        
Tax Rate (4)         44.9 %       22.3 %      
* 100% or greater  
 
(1) Amounts include the impact of acquisition and divestiture-related costs, restructuring costs and certain other items. See accompanying tables for details.
 
(2) Research and development expenses in the first quarter of 2018 include a $1.4 billion aggregate charge related to the formation of a collaboration with Eisai Co., Ltd (Eisai).
 
(3) Represents separation and other related costs associated with restructuring activities under the company's formal restructuring programs.
 
(4) The effective income tax rate for the first quarter of 2018 reflects the unfavorable impact of a $1.4 billion aggregate pretax charge related to the formation of a collaboration with Eisai for which no tax benefit was recognized.
MERCK & CO., INC.
GAAP TO NON-GAAP RECONCILIATION
FIRST QUARTER 2018
(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)
(UNAUDITED)
Table 2a
                                       
        GAAP    

Acquisition and
Divestiture-Related
Costs (1)

   

Restructuring
Costs (2)

   

Certain Other
Items (3)

   

Adjustment
Subtotal

  Non-GAAP
Materials and production       $ 3,184       734         6                 740       $ 2,444  
Marketing and administrative         2,508       8         1                 9         2,499  
Research and development         3,196       1         2         1,400         1,403         1,793  
Restructuring costs         95               95                 95         -  
Other (income) expense, net         (291 )     (10 )               (22 )       (32 )       (259 )
Income Before Taxes         1,345       (733 )       (104 )       (1,378 )       (2,215 )       3,560  
Income Tax Provision (Benefit)         604       (91 )

(4)

    (21 )

(4)

    5  

(4)

    (107 )       711  
Net Income         741       (642 )       (83 )       (1,383 )       (2,108 )       2,849  
Net Income Attributable to Merck & Co., Inc.         736       (642 )       (83 )       (1,383 )       (2,108 )       2,844  
Earnings per Common Share Assuming Dilution       $ 0.27       (0.24 )       (0.03 )       (0.51 )       (0.78 )     $ 1.05  
                                             
Tax Rate         44.9 %                                     20.0 %
Only the line items that are affected by non-GAAP adjustments are shown.  
 
Merck is providing certain non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing this information enhances investors’ understanding of the company’s results as it permits investors to understand how management assesses performance. Management uses these measures internally for planning and forecasting purposes and to measure the performance of the company along with other metrics. Senior management’s annual compensation is derived in part using non-GAAP income and non-GAAP EPS. This information should be considered in addition to, but not as a substitute for or superior to, information prepared in accordance with GAAP.
 
(1) Amounts included in materials and production costs reflect expenses for the amortization of intangible assets recognized as a result of business acquisitions. Amounts included in marketing and administrative expenses reflect integration, transaction and certain other costs related to business acquisitions and divestitures. Amounts included in research and development expenses reflect increases in the estimated fair value measurement of liabilities for contingent consideration. Amounts included in other (income) expense, net reflect royalty income, partially offset by an increase in the estimated fair value measurement of liabilities for contingent consideration.
 
(2) Amounts primarily include employee separation costs and accelerated depreciation associated with facilities to be closed or divested related to activities under the company's formal restructuring programs.
 
(3) Amount included in research and development expenses represents an aggregate charge related to the formation of a collaboration with Eisai Co., Ltd.
 
(4) Represents the estimated tax impact on the reconciling items based on applying the statutory rate of the originating territory of the non-GAAP adjustments.
MERCK & CO., INC.
FRANCHISE / KEY PRODUCT SALES
(AMOUNTS IN MILLIONS)
Table 3
                                                 
      2018     2017     1Q
      1Q     1Q     2Q     3Q     4Q     Full Year     Nom %     Ex-Exch %
                                                 
TOTAL SALES (1)     $ 10,037     $ 9,434     $ 9,930     $ 10,325     $ 10,433     $ 40,122     6     3
PHARMACEUTICAL       8,919       8,185       8,759       9,156       9,290       35,390     9     4
Oncology                                                
Keytruda       1,464       584       881       1,047       1,297       3,809     151     142
Emend       125       133       143       137       143       556     -5     -9
Temodar       57       66       65       68       73       271     -13     -18
Alliance Revenue – Lynparza       33                   5       16       20            
Vaccines (2)                                                
Gardasil / Gardasil 9       660       532       469       675       633       2,308     24     20
ProQuad / M-M-R II / Varivax       392       355       399       519       403       1,676     10     9
RotaTeq       193       224       123       179       160       686     -14     -15
Pneumovax 23       179       163       166       229       263       821     9     7
Zostavax       65       154       160       234       121       668     -58     -60
Hospital Acute Care                                                
Bridion       204       148       163       185       209       704     38     31
Noxafil       176       141       155       162       179       636     24     17
Invanz       151       136       150       159       157       602     11     8
Cubicin       98       96       103       91       92       382     2     -2
Cancidas       91       121       112       94       95       422     -25     -31
Primaxin       72       62       71       73       74       280     15     9
Immunology                                                
Simponi       231       184       199       219       217       819     26     11
Remicade       167       229       208       214       186       837     -27     -35
Neuroscience                                                
Belsomra       54       42       52       56       60       210     31     27
Virology                                                
Isentress / Isentress HD       281       305       282       310       308       1,204     -8     -12
Zepatier       131       378       517       468       296       1,660     -65     -69
Cardiovascular                                                
Zetia       305       334       367       320       323       1,344     -9     -17
Vytorin       167       241       182       142       186       751     -31     -38
Atozet       73       49       63       59       54       225     47     30
Adempas       68       84       67       70       79       300     -19     -25
Diabetes (3)                                                
Januvia       880       839       948       1,012       938       3,737     5     1
Janumet       544       496       563       513       586       2,158     10     4
Women's Health                                                
NuvaRing       216       160       199       214       188       761     36     32
Implanon / Nexplanon       174       170       178       155       183       686     2     1
Diversified Brands                                                
Singulair       175       186       203       161       182       732     -6     -12
Nasonex       122       139       85       42       120       387     -12     -17
Cozaar / Hyzaar       120       112       119       128       125       484     7     0
Arcoxia       83       103       89       80       91       363     -20     -25
Follistim AQ       67       81       79       72       66       298     -17     -22
Dulera       57       82       69       59       77       287     -31     -31
Fosamax       55       61       66       53       62       241     -9     -17
Other Pharmaceutical (4)       989       995       1,064       952       1,048       4,065     -1     -6
                                                 
ANIMAL HEALTH       1,065       939       955       1,000       981       3,875     13     7
Livestock       652       578       591       647       668       2,484     13     6
Companion Animals       413       361       364       353       313       1,391     14     9
                                                 
Other Revenues (5)       53       310       216       169       162       857     -83     -19
Sum of quarterly amounts may not equal year-to-date amounts due to rounding.
   

(1) Only select products are shown.

 
(2) Total Vaccines sales were $1,561 million in the first quarter of 2018 and $1,516 million, $1,404 million, $1,924 million and $1,704 million for the first, second, third and fourth quarters of 2017, respectively.
 
(3) Total Diabetes sales were $1,433 million in the first quarter of 2018 and $1,338 million, $1,520 million, $1,531 million and $1,533 million for the first, second, third and fourth quarters of 2017, respectively.
 
(4) Includes Pharmaceutical products not individually shown above.
 
(5) Other Revenues are comprised primarily of Healthcare Services segment revenues, third-party manufacturing sales and miscellaneous corporate revenues, including revenue hedging activities.

 

Contacts

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

Source: Merck

 

 

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