Merck Announces Fourth-Quarter and Full-Year 2015 Financial Results

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced financial results for the fourth quarter and full year of 2015.

"The past year was one of considerable progress and execution for Merck," said Kenneth C. Frazier, chairman and chief executive officer, Merck. "I'm excited by the near-term opportunities, as we continue launching important new products like ZEPATIER and KEYTRUDA while augmenting and advancing our pipeline."

            Financial Summary   Fourth Quarter   Year Ended               Dec. 31,   Dec. 31,   $ in millions, except EPS amounts   2015   2014   2015   2014   Sales   $10,215   $10,482   $39,498   $42,237   GAAP EPS   0.35   2.54   1.56   4.07  

Non-GAAP EPS that excludes items listed below1

  0.93   0.87   3.59   3.49  

GAAP net income2

  976   7,316   4,442   11,920   Non-GAAP net income that excludes items listed below1,2   2,608   2,504   10,195   10,215                      

Non-GAAP (generally accepted accounting principles) earnings per share (EPS) of $0.93 for the fourth quarter and $3.59 for the full year of 2015 exclude acquisition- and divestiture-related costs, restructuring costs and certain other items, as well as a net charge to settle Vioxx shareholder class action litigation.

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

                Fourth Quarter   Year Ended               Dec. 31,   Dec. 31,   $ in millions, except EPS amounts   2015   2014   2015   2014   EPS                   GAAP EPS   $0.35   $2.54   $1.56   $4.07  

Difference3

  0.58   (1.67)   2.03   (0.58)   Non-GAAP EPS that excludes items listed below1   $ 0.93   $0.87   $3.59   $3.49                       Net Income                   GAAP net income2   $976   $7,316   $4,442   $11,920   Difference   1,632   (4,812)   5,753   (1,705)   Non-GAAP net income that excludes items listed below1,2   $2,608   $2,504   $10,195   $10,215                       Decrease (Increase) in Net Income Due to Excluded Items:                  

Acquisition- and divestiture-related costs4

  $ 1,264   $1,394   $5,398   $5,946   Restructuring costs   340   619   1,110   1,978   Net charge to settle Vioxx shareholder class action litigation   680   –   680   –   Foreign exchange losses related to Venezuela   161   –   876   –   Loss on extinguishment of debt   –   628   –   628   Additional year of health care reform fee   –   –   –   193   Gain on divestiture of certain ophthalmic products   (147)   (84)   (147)   (480)   Gain on divestiture of certain migraine clinical development programs   –   –   (250)   –   Gain on sale of Merck Consumer Care   –   (11,209)   –   (11,209)   Gain on AstraZeneca option exercise   –   –   –   (741)   Other   13   (14)   (34)   (9)   Net decrease (increase) in income before taxes   2,311   (8,666)   7,633   (3,694)  

Income tax (benefit) expense5

  (679)   3,854   (1,880)   2,045   Acquisition- and divestiture-related costs attributable to non-controlling interests   –   –   –   (56)   Decrease (increase) in net income   $1,632   $(4,812)   $5,753   $(1,705)  

1 Merck is providing certain 2015 and 2014 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 performance. This information should be considered in addition to, but not in lieu of, information prepared in accordance with GAAP. For description of the items, see Tables 2a and 2b, including the related footnotes, attached to this release.

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

3 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.

4 Includes expenses for the amortization of intangible assets 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 costs, as well as transaction and certain other costs related to business acquisitions and divestitures.

5 Includes the estimated tax impact on the reconciling items. In addition, amounts for fourth-quarter and full-year 2015 include net benefits of $40 million and $410 million, respectively, related to the settlement of certain federal income tax issues. Additionally, amount for full-year 2014 includes a net benefit of $517 million recorded in connection with AstraZeneca's option exercise, as well as a benefit of approximately $300 million associated with a capital loss generated in the first quarter.

Additional Executive Commentary

"In 2016 we will build upon the strong foundation we established last year. We will continue to invest resources to launch and grow our strongest brands, support the most promising internal assets, enhance our pipeline with the best available external science and maintain a balanced and differentiated portfolio, with the goal of delivering long-term growth and shareholder value," said Frazier.

"Global Human Health delivered a solid performance in 2015," said Adam Schechter, president, Global Human Health, Merck. "In 2016 we will continue to prioritize resources focusing on JANUVIA, on our key launches, including KEYTRUDA and ZEPATIER, and on our hospital acute care and vaccines businesses."

"We will pursue numerous filings and approvals in 2016," said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. "For example, we view KEYTRUDA as foundational in the next-generation treatment of malignant disease, and hence have embarked upon an exceptionally broad development program for this agent, with registration-enabling studies underway in more than a dozen tumor types. We will also pursue more than 100 studies involving combinations of KEYTRUDA with other drugs."

"The fourth quarter was a strong finish to a solid year of execution. We expect this momentum to continue into 2016, as we further innovate in our labs, invest behind our launches and continue our focus on disciplined resource allocation and continuous productivity to deliver a leveraged P&L and shareholder returns," said Robert Davis, chief financial officer, Merck.

Select Business Highlights

Worldwide sales were $10.2 billion for the fourth quarter of 2015, a decrease of 3 percent compared with the fourth quarter of 2014, including a 7 percent negative impact from foreign exchange and a 3 percent net positive impact primarily from the acquisition of Cubist Pharmaceuticals, Inc. (Cubist). Full-year 2015 worldwide sales were $39.5 billion, a decrease of 6 percent compared with the full year of 2014, including a 6 percent negative impact from foreign exchange and a 3 percent net negative impact resulting from the divestiture of the Consumer Care business and select products, partially offset by the Cubist acquisition.

The following table reflects sales of the company's top pharmaceutical products, as well as total sales of Animal Health and Consumer Care products.

                           

 

$ in millions

  Fourth Quarter  

Change

  Change

Ex-

Exchange

  Year Ended   Change   Change

Ex-

Exchange

    2015   2014       Dec. 31,

2015

  Dec. 31,

2014

      Total Sales   $10,215   $10,482   -3%   4%   $39,498   $42,237   -6%   0%   Pharmaceutical   9,027   9,370   -4%   4%   34,782   36,042   -3%   4%  

JANUVIA /
JANUMET

  1,447   1,652   -12%   -6%   6,014   6,002   0%   7%  

ZETIA /
VYTORIN

  999   1,032   -3%   4%   3,777   4,166   -9%   -2%  

GARDASIL /
GARDASIL 9

  497   356   40%   42%   1,908   1,738   10%   11%   PROQUAD, M-M-R II and VARIVAX   409   366   12%   14%   1,505   1,394   8%   10%   REMICADE   396   557   -29%   -18%   1,794   2,372   -24%   -10%   ISENTRESS   374   418   -11%   -4%   1,511   1,673   -10%   -2%   CUBICIN   322   7*   **   **   1,127   25*   **   **   SINGULAIR   273   319   -14%   -7%   931   1,092   -15%   -5%   ZOSTAVAX   246   285   -14%   -11%   749   765   -2%   0%   NASONEX   231   268   -14%   -8%   858   1,099   -22%   -16%   KEYTRUDA   214   50   **   **   566   55   **   **   Animal Health   830   885   -6%   8%   3,324   3,454   -4%   9%   Consumer Care***   –   16   **   **   3   1,547   **   **   Other Revenues   358   211   69%   19%   1,389   1,194   16%   -33%   *Reflects licensing agreement with Cubist in Japan prior to acquisition by Merck on Jan. 21, 2015 **≥100% ***divested on Oct. 1, 2014

Commercial and Pipeline Highlights

The company continued to make steady progress in advancing its late-stage pipeline, achieving key regulatory approvals and expanded indications for multiple products across its portfolio.

  • The U.S. Food and Drug Administration (FDA) approved ZEPATIER (elbasvir and grazoprevir), a once-daily, fixed-dose combination tablet for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype (GT) 1 or GT4 infection, with or without ribavirin. ZEPATIER was approved for use in a broad range of chronic HCV patients, including those with compensated cirrhosis, renal impairment of any degree and HIV-1/HCV co-infection.
  • Merck significantly advanced its development program for KEYTRUDA (pembrolizumab), an anti-PD-1 therapy for the treatment of metastatic non-small cell lung cancer (NSCLC) in previously treated patients whose tumors express PD-L1, as well as advanced melanoma.
    • The FDA approved KEYTRUDA for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 as determined by an FDA-approved test and who have disease progression on or after platinum-containing chemotherapy across both squamous and non-squamous metastatic NSCLC.
    • The FDA approved an expanded indication for KEYTRUDA for the first-line treatment of patients with unresectable or metastatic melanoma regardless of BRAF status and an update to the product labeling for KEYTRUDA for the treatment of patients with ipilimumab-refractory advanced melanoma.
    • KEYTRUDA received a third Breakthrough Therapy Designation from the FDA for the treatment of patients with microsatellite instability high metastatic colorectal cancer.
    • Results from the pivotal KEYNOTE-010 study were published in The Lancet and presented at the European Society for Medical Oncology Asia 2015 Congress, showing superior overall survival compared to chemotherapy in patients with previously treated advanced NSCLC whose tumors express PD-L1. Based on these data, the company has submitted a supplemental Biologics License Application to the FDA and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA).
    • During the fourth quarter of 2015, the company entered into collaborations with GSK and Amgen. Additionally, the company extended an existing collaboration with Eli Lilly and Company (Lilly) and entered into a new collaboration with Lilly to study KEYTRUDA in combination settings.
    • The KEYTRUDA clinical trials program currently includes more than 30 tumor types in more than 200 clinical trials, including more than 100 trials that combine KEYTRUDA with other cancer treatments. Registration-enabling trials of KEYTRUDA are currently enrolling patients with melanoma, NSCLC, head and neck cancer, bladder cancer, gastric cancer, colorectal cancer, esophageal cancer, Hodgkin lymphoma, multiple myeloma and breast cancer, and further trials are being planned for other malignancies.
  • The company strengthened its oncology pipeline by acquiring IOmet Pharma Ltd (IOmet) in early 2016. IOmet is a drug discovery company focused on the development of innovative medicines for the treatment of cancer, with a particular emphasis on the fields of cancer immunotherapy and cancer metabolism.
  • BRIDION (sugammadex) Injection 100 mg/mL was approved by the FDA for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery.
  • The Biologics License Application for bezlotoxumab, an investigational antitoxin for the prevention of Clostridium difficile (C. difficile) infection recurrence, was accepted by the FDA for priority review with a PDUFA action date of July 23, 2016. The company also has filed a MAA for bezlotoxumab with the EMA that is currently under review.

Pharmaceutical Revenue Performance

Fourth-quarter pharmaceutical sales declined 4 percent to $9.0 billion, including an 8 percent negative impact from foreign exchange. Excluding the impact of exchange, growth was driven by sales in hospital acute care, oncology and vaccines. Growth in hospital acute care was driven by the addition of the Cubist portfolio and sales growth of certain inline brands. Growth in oncology reflects higher sales of KEYTRUDA. Growth in vaccines reflects higher sales of GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant), a vaccine to prevent cancers and other diseases caused by HPV, reflecting an increase in sales in the United States primarily due to public sector purchases, and higher sales of PROQUAD (Measles, Mumps, Rubella and Varicella Vaccine Live) driven by the timing of sales activity related to the Pediatric Vaccine Stockpile of the U.S. Centers for Disease Control and Prevention.

Fourth-quarter pharmaceutical sales reflect a decrease in PNEUMOVAX 23 (pneumococcal vaccine polyvalent), due to near-term market dynamics in the United States and the timing of vaccinations linked to the National Immunization Program in Japan, as well as lower sales in the diabetes franchise of JANUVIA (sitagliptin)/JANUMET (sitagliptin and metformin HCl), medicines that help lower blood sugar in adults with type 2 diabetes, driven in large part by an expected decline due to the timing of customer purchases in the third quarter of 2015. Pharmaceutical sales also reflect declines in REMICADE (infliximab), a treatment for inflammatory diseases, due to loss of exclusivity and the accelerating impact of biosimilar competition in the company's marketing territories in Europe, and PEGINTRON (peginterferon alfa-2b), a medicine to treat chronic HCV.

Full-year 2015 pharmaceutical sales declined 3 percent to $34.8 billion, including a 7 percent negative impact from foreign exchange. Excluding the impact of exchange, growth was driven by sales in hospital acute care, oncology, diabetes and vaccines.

Animal Health Revenue Performance

Animal Health sales totaled $830 million for the fourth quarter of 2015, a decrease of 6 percent compared with the fourth quarter of 2014, including a 14 percent negative impact from foreign exchange. Worldwide sales for the full year of 2015 were $3.3 billion, a decrease of 4 percent, including a 13 percent negative impact from foreign exchange. Excluding the impact of exchange, growth in both periods was primarily driven by an increase in sales of companion animal products, including continued strong growth from BRAVECTO (fluralaner), a chewable tablet that kills fleas and ticks in dogs for up to 12 weeks, and aqua and swine products.

Fourth-Quarter and Full-Year 2015 Expense and Other Information

The tables below present selected expense information for the fourth quarter and full year of 2015.

        $ in millions   Included in expenses for the period           Acquisition- and           Fourth Quarter       Divestiture-   Restructuring       2015   GAAP  

Related Costs4

  Costs   Non-GAAP(1)   Materials and production   $3,850   $1,194   $81   $2,575   Marketing and administrative   2,615   47   8   2,560   Research and development   1,797   (24)   18   1,803   Restructuring costs   233   –   233   –   Fourth Quarter

2014

                  Materials and production   $3,749   $984   $105   $2,660   Marketing and administrative   2,924   81   57   2,786   Research and development   2,283   329   108   1,846   Restructuring costs   349   –   349   –                                   $ in millions   Included in expenses for the period           Acquisition-                       and Divestiture-               Year Ended       Related   Restructuring   Certain       Dec. 31, 2015   GAAP  

Costs4

  Costs   Other Items   Non-GAAP(1)   Materials and production   $14,934   $4,869   $361   $–   $9,704   Marketing and administrative   10,313   436   78   –   9,799   Research and development   6,704   39   52   –   6,613   Restructuring costs   619   –   619   –   –   Year Ended

Dec. 31, 2014

                      Materials and production   $16,768   $5,254   $482   $–   $ 11,032   Marketing and administrative   11,606   234   200   193   10,979   Research and development   7,180   365   283   –   6,532   Restructuring costs   1,013   –   1,013   –   –                          

The gross margin was 62.3 percent for the fourth quarter of 2015 compared to 64.2 percent for the fourth quarter of 2014, reflecting 12.5 and 10.4 unfavorable percentage point impacts, respectively, from the acquisition- and divestiture-related costs and restructuring costs noted above. The gross margin was 62.2 percent for the full year of 2015 compared to 60.3 percent for the full year of 2014, reflecting 13.2 and 13.6 unfavorable percentage point impacts, respectively, from the acquisition- and divestiture-related costs and restructuring costs noted above. The rate increases in non-GAAP gross margin for the fourth quarter and full year of 2015 reflect the favorable impact of foreign exchange and lower inventory write-offs.

Marketing and administrative expenses, on a non-GAAP basis, were $2.6 billion in the fourth quarter of 2015, a decrease from $2.8 billion in the same period of 2014, which was primarily driven by the favorable impact of foreign exchange and operational efficiencies, partially offset by investments in key brands. Full-year 2015 marketing and administrative expenses, on a non-GAAP basis, were $9.8 billion, a decrease from $11.0 billion in 2014, which was primarily driven by the favorable impact of foreign exchange and the sale of the Consumer Care business, partially offset by investments in key brands.

Research and development (R&D) expenses, on a non-GAAP basis, were $1.8 billion in the fourth quarter of 2015, a 2 percent decrease compared to the fourth quarter of 2014. Full-year R&D expenses in 2015, on a non-GAAP basis, were $6.6 billion, an increase from $6.5 billion in 2014.

Other (income) expense, net, was $905 million of expense in the fourth quarter of 2015 compared to $10.6 billion of income in the fourth quarter of 2014 and $1.5 billion of expense for the full year of 2015 compared to $11.6 billion of income for the full year of 2014. Other (income) expense, net for the fourth quarter and full year of 2015 includes $161 million and $876 million, respectively, of foreign exchange losses related to the revaluation of the company's net monetary assets in Venezuela and a $680 million net charge to settle Vioxx shareholder class action litigation. Other (income) expense, net in both the fourth quarter and full year of 2014 includes an $11.2 billion gain on the divestiture of the Consumer Care business and a $628 million loss on the extinguishment of debt.

The GAAP effective tax rates of (20.4) percent for the fourth quarter of 2015 and 17.4 percent for the full year of 2015 reflect the impacts of acquisition- and divestiture-related costs, restructuring costs and certain other items, including the impact of the net charge to settle Vioxx shareholder class action litigation being fully deductible at combined U.S. federal and state tax rates, as well as the unfavorable impact of non-deductible foreign exchange losses related to Venezuela. In addition, the GAAP effective tax rates for the fourth quarter and full year of 2015 include net benefits of $40 million and $410 million, respectively, related to the settlement of certain federal tax issues. The non-GAAP effective tax rates, which exclude these items, were 16.4 percent for the fourth quarter and 21.7 percent for the full year of 2015. Both the GAAP and non-GAAP effective tax rates for the fourth quarter and full year of 2015 include the favorable impact of tax legislation, including the renewal of the R&D tax credit, enacted in the fourth quarter of 2015.

Financial Outlook

Merck expects its full-year 2016 GAAP EPS to be between $1.96 and $2.23. Merck expects its full-year 2016 non-GAAP EPS to be between $3.60 and $3.75, including an approximately 4 percent negative impact from foreign exchange. The non-GAAP range excludes acquisition- and divestiture-related costs and costs related to restructuring programs.

At mid-January 2016 exchange rates, Merck anticipates full-year 2016 revenues to be between $38.7 billion and $40.2 billion, including an approximately 3 percent negative impact from foreign exchange.

In addition, the company expects full-year 2016 non-GAAP marketing and administrative expenses to be below 2015 levels and R&D expenses to be modestly above 2015 levels.

The company anticipates its full-year 2016 non-GAAP tax rate will be in the range of 21.5 to 22.5 percent, including a 2016 R&D tax credit.

A reconciliation of anticipated 2016 EPS, as reported in accordance with GAAP to non-GAAP EPS that excludes certain items, is provided in the table below.

          Full Year $ in millions, except EPS amounts   2016 GAAP EPS   $1.96 to $2.23 Difference3   1.64 to 1.52 Non-GAAP EPS that excludes items listed below   $3.60 to $3.75       Acquisition- and divestiture-related costs   $4,600 to $4,400 Restructuring costs   900 to 700 Net decrease (increase) in income before taxes   5,500 to 5,100 Estimated income tax (benefit) expense   (935) to (860) Decrease (increase) in net income   $4,565 to $4,240      

Total Employees

As of Dec. 31, 2015, Merck had approximately 68,000 employees worldwide.

Earnings Conference Call

Investors, journalists and the general public may access a live audio webcast of the call today at 8:00 a.m. EST on Merck's website at http://www.merck.com/investors/events-and-presentations/home.html. Institutional investors and analysts can participate in the call by dialing (706) 758-9927 or (877) 381-5782 and using ID code number 4404803. Members of the media are invited to monitor the call by dialing (706) 758-9928 or (800) 399-7917 and using ID code number 4404803. 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

Today's Merck is a global health care leader working to help the world be well. Merck is known as MSD outside the United States and Canada. 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. For more information, visit www.merck.com and connect with us on TwitterFacebookYouTube 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 2014 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).

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

GAAP

     

GAAP

        4Q15   4Q14  

% Change

 

Full Year
2015

 

Full Year
2014

 

% Change

                                    Sales   $ 10,215   $ 10,482   -3%   $ 39,498   $ 42,237   -6%                           Costs, Expenses and Other                         Materials and production (1)   3,850   3,749   3%   14,934   16,768   -11% Marketing and administrative (1)   2,615   2,924   -11%   10,313   11,606   -11% Research and development (1)   1,797   2,283   -21%   6,704   7,180   -7% Restructuring costs (2)   233   349   -33%   619   1,013   -39% Other (income) expense, net (1) (3)   905   (10,634)   *   1,527   (11,613)   * Income Before Taxes   815   11,811   -93%   5,401   17,283   -69% Income Tax (Benefit) Provision   (166)   4,484       942   5,349     Net Income   981   7,327   -87%   4,459   11,934   -63% Less: Net Income Attributable to Noncontrolling Interests   5   11       17   14     Net Income Attributable to Merck & Co., Inc.   $ 976   $ 7,316   -87%   $ 4,442   $ 11,920   -63% Earnings per Common Share Assuming Dilution   $ 0.35   $ 2.54   -86%   $ 1.56   $ 4.07   -62%                           Average Shares Outstanding Assuming Dilution   2,813   2,880       2,841   2,928     Tax Rate (4)   -20.4%   38.0%       17.4%   30.9%                              

* 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) Represents separation and other related costs associated with restructuring activities under the company's formal restructuring programs.

(3) Other (income) expense, net in the fourth quarter and full year of 2015 includes a $680 million net charge to settle VIOXX shareholder class action litigation, as well as a $147 million gain on the divestiture of the company's remaining ophthalmics business in international markets. Other (income) expense, net in the fourth quarter and full year of 2015 includes foreign exchange losses of $161 million and $876 million, respectively, to revalue the company's net monetary assets in Venezuela. Other (income) expense, net for the full year of 2015 also includes a $250 million gain on the sale of certain migraine clinical development programs.

Other (income) expense, net in the fourth quarter and full year of 2014 includes an $11.2 billion gain on the divestiture of Merck's Consumer Care business and a $628 million loss on the extinguishment of debt. Other (income) expense, net for the full year of 2014 also includes a gain of $741 million related to AstraZeneca's option exercise, a gain of $480 million on the divestiture of certain ophthalmic products in several international markets, and a gain of $204 million related to the divestiture of the company's Sirna Therapeutics, Inc. subsidiary, as well as a $93 million goodwill impairment charge related to the company's joint venture with Supera Farma Laboratorios S.A.

Other (income) expense, net includes equity income from affiliates. Prior period amounts have been reclassified to conform to the current presentation.

(4) The effective income tax rates for the fourth quarter and full year of 2015 reflect the impact of the net charge to settle VIOXX shareholder class action litigation being fully deductible at combined U.S. federal and state tax rates, as well as the favorable impact of tax legislation enacted in the fourth quarter of 2015, partially offset by the unfavorable impact of non-deductible foreign exchange losses recorded in connection with the revaluation of the company's net monetary assets in Venezuela. The effective income tax rates for the fourth quarter and full year of 2015 also reflect net benefits of $40 million and $410 million, respectively, related to the settlement of certain federal income tax issues.

The effective income tax rates for the fourth quarter and full year of 2014 include the impact of the gain on the divestiture of Merck's Consumer Care business being taxed primarily at combined U.S. federal and state tax rates. The effective income tax rates for the fourth quarter and full year of 2014 also reflect the favorable impact of tax legislation enacted in the fourth quarter of 2014. In addition, the effective income tax rate for the full year of 2014 reflects a net benefit of $517 million recorded in connection with AstraZeneca's option exercise, as well as a benefit of approximately $300 million associated with a capital loss generated in the first quarter of 2014.

  MERCK & CO., INC. CONSOLIDATED STATEMENT OF INCOME GAAP TO NON-GAAP RECONCILIATION FOURTH QUARTER 2015 (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                                                         Sales   $ 10,215                       $ 10,215                               Costs, Expenses and Other                           Materials and production     3,850     1,194     81         1,275         2,575   Marketing and administrative     2,615     47     8         55         2,560   Research and development     1,797     (24 )   18         (6 )       1,803   Restructuring costs     233         233         233         -   Other (income) expense, net (4)     905     47         707     754         151   Income Before Taxes     815     (1,264 )   (340 )   (707 )   (2,311 )       3,126   Income Tax (Benefit) Provision     (166 )               (679 )

(5)

    513   Net Income     981                 (1,632 )       2,613   Less: Net Income Attributable to Noncontrolling Interests     5                         5   Net Income Attributable to Merck & Co., Inc.   $ 976                 (1,632 )     $ 2,608   Earnings per Common Share Assuming Dilution   $ 0.35                       $ 0.93                               Average Shares Outstanding Assuming Dilution     2,813                         2,813   Tax Rate     -20.4 %                       16.4 %                                    

Merck is providing 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 performance. This information should be considered in addition to, but not in lieu of, information prepared in accordance with GAAP.

(1) Amounts included in materials and production costs reflect $1.1 billion of expenses for the amortization of intangible assets recognized as a result of acquisitions, as well as $29 million of amortization of purchase accounting adjustments to inventories as a result of the Cubist acquisition, and $33 million of impairment charges on intangible assets. Amounts included in marketing and administrative expenses reflect integration, transaction and certain other costs related to business acquisitions, including severance costs which are not part of the company's formal restructuring programs, as well as transaction and certain other costs related to divestitures. Amounts included in research and development expenses primarily reflect income of $25 million resulting from a reduction in the estimated fair value of liabilities for contingent consideration. Amounts included in other (income) expense, net represent goodwill impairment charges related to certain of Merck's Healthcare Services businesses.

(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) Primarily reflects a $680 million net charge to settle VIOXX shareholder class action litigation, foreign exchange losses of $161 million to revalue the company's net monetary assets in Venezuela and a $147 million gain on the divestiture of the company's remaining ophthalmics business in international markets.

(4) Other (income) expense, net includes equity income from affiliates.

(5) Represents the estimated tax impact on the reconciling items, as well as a net benefit of $40 million on the settlement of certain federal income tax issues.

                            MERCK & CO., INC. CONSOLIDATED STATEMENT OF INCOME GAAP TO NON-GAAP RECONCILIATION YEAR ENDED DECEMBER 31, 2015 (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                             Sales   $ 39,498                       $ 39,498                               Costs, Expenses and Other                           Materials and production     14,934     4,869     361         5,230         9,704   Marketing and administrative     10,313     436     78         514         9,799   Research and development     6,704     39     52         91         6,613   Restructuring costs     619         619         619         -   Other (income) expense, net (4)     1,527     54         1,125     1,179         348   Income Before Taxes     5,401     (5,398 )   (1,110 )   (1,125 )   (7,633 )       13,034   Taxes on Income     942                 (1,880 )

(5)

    2,822   Net Income     4,459                 (5,753 )       10,212   Less: Net Income Attributable to Noncontrolling Interests     17                         17   Net Income Attributable to Merck & Co., Inc.   $ 4,442                 (5,753 )     $ 10,195   Earnings per Common Share Assuming Dilution   $ 1.56                       $ 3.59                               Average Shares Outstanding Assuming Dilution     2,841                         2,841   Tax Rate     17.4 %                       21.7 %                                    

Merck is providing 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 performance. This information should be considered in addition to, but not in lieu of, information prepared in accordance with GAAP.

(1) Amounts included in materials and production costs reflect $4.7 billion of expenses for the amortization of intangible assets recognized as a result of acquisitions, as well as $105 million of amortization of purchase accounting adjustments to inventories as a result of the Cubist acquisition, and $45 million of impairment charges on intangible assets. Amounts included in marketing and administrative expenses reflect integration, transaction and certain other costs related to business acquisitions, including severance costs which are not part of the company's formal restructuring programs, as well as transaction and certain other costs related to divestitures. Amounts included in research and development expenses reflect $63 million of in-process research and development (IPR&D) impairment charges and income of $24 million resulting from a reduction in the estimated fair value of liabilities for contingent consideration. Amounts included in other (income) expense, net represent goodwill impairment charges related to certain of Merck's Healthcare Services businesses.

(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) Primarily reflects foreign exchange losses of $876 million to revalue the company's net monetary assets in Venezuela, a $680 million net charge to settle VIOXX shareholder class action litigation, a $250 million gain on the divestiture of certain migraine clinical development programs and a $147 million gain on the divestiture of the company's remaining ophthalmics business in international markets.

(4) Other (income) expense, net includes equity income from affiliates.

(5) Represents the estimated tax impact on the reconciling items, as well as a net benefit of $410 million on the settlement of certain federal income tax issues.

                                                    MERCK & CO., INC.   FRANCHISE / KEY PRODUCT SALES   (AMOUNTS IN MILLIONS)   Table 3                       2015   2014   % Change                       Full                   Full       Full       1Q   2Q   3Q   4Q   Year   1Q   2Q   3Q   4Q   Year   4Q   Year   TOTAL SALES (1)   $ 9,425   $ 9,785   $ 10,073   $ 10,215   $ 39,498   $ 10,264   $ 10,934   $ 10,557   $ 10,482   $ 42,237   -3   -6   PHARMACEUTICAL     8,266     8,564     8,925     9,027     34,782     8,451     9,087     9,134     9,370     36,042   -4   -3   Primary Care & Women's Health                                               Cardiovascular                                                   Zetia     568     635     633     691     2,526     611     717     660     662     2,650   4   -5   Vytorin     320     320     302     308     1,251     361     417     369     370     1,516   -17   -17   Diabetes                                                   Januvia     884     1,044     1,014     921     3,863     858     1,058     933     1,082     3,931   -15   -2   Janumet     509     554     562     526     2,151     476     519     505     570     2,071   -8   4   General Medicine & Women's Health                                               NuvaRing     166     182     190     193     732     168     178     186     191     723   1   1   Implanon / Nexplanon     137     124     176     151     588     102     119     158     123     502   23   17   Dulera     130     120     133     153     536     102     103     124     132     460   16   16   Follistim AQ     82     111     95     95     383     110     102     97     102     412   -7   -7   Hospital and Specialty                                                   Hepatitis                                                   PegIntron     56     52     40     34     182     112     103     84     81     381   -58   -52   HIV                                                   Isentress     385     375     377     374     1,511     390     453     412     418     1,673   -11   -10   Hospital Acute Care                                                   Cubicin(2)     187     293     325     322     1,127     5     6     7     7     25   *   *   Cancidas     163     134     139     137     573     166     156     183     175     681   -22   -16   Invanz     132     139     153     144     569     114     134     141     139     529   4   8   Noxafil     111     117     132     128     487     74     98     107     122     402   4   21   Bridion     85     87     89     92     353     73     82     90     95     340   -3   4   Primaxin     65     88     75     86     313     71     81     91     86     329   0   -5   Immunology                                                   Remicade     501     455     442     396     1,794     604     607     604     557     2,372   -29   -24   Simponi     158     169     178     185     690     157     174     170     188     689   -2   0   Oncology                                                   Keytruda     83     110     159     214     566     0     0     4     50     55   *   *   Emend     122     134     141     139     535     122     144     136     151     553   -8   -3   Temodar     74     80     83     75     312     83     93     88     86     350   -14   -11   Diversified Brands                                                   Respiratory                                                   Singulair     245     212     201     273     931     271     284     218     319     1,092   -14   -15   Nasonex     289     215     121     231     858     312     258     261     268     1,099   -14   -22   Clarinex     51     55     39     42     187     62     69     49     52     232   -20   -20   Other                                                   Cozaar / Hyzaar     185     189     150     143     667     205     214     195     192     806   -25   -17   Arcoxia     123     115     123     110     471     128     141     132     118     519   -7   -9   Fosamax     94     96     86     82     359     123     121     114     112     470   -27   -24   Zocor     49     63     56     49     217     64     69     61     64     258   -22   -16   Propecia     53     39     41     50     183     74     58     66     67     264   -26   -31   Vaccines                                                   Gardasil / Gardasil 9     359     427     625     497     1,908     383     409     590     356     1,738   40   10   ProQuad, M-M-R II and Varivax     348     358     390     409     1,505     280     326     421     366     1,394   12   8   Zostavax     175     149     179     246     749     142     156     181     285     765   -14   -2   RotaTeq     192     89     160     169     610     169     147     174     169     659   0   -7   Pneumovax 23     110     106     138     188     542     101     102     197     346     746   -46   -27   Other Pharmaceutical (3)     1,075     1,128     1,178     1,174     4,553     1,378     1,389     1,326     1,269     5,356   -7   -15                                                       ANIMAL HEALTH     829     840     825     830     3,324     813     872     885     885     3,454   -6   -4                                                       CONSUMER CARE (4)     2     0     0     0     3     546     583     401     16     1,547   *   *                                                       Other Revenues (5)     328     381     323     358     1,389     454     392     137     211     1,194   69   16                                                                          

* 100% or greater

Sum of quarterly amounts may not equal year-to-date amounts due to rounding.

(1) Only select products are shown.

(2) Cubicin results for the first quarter 2015 represent sales for the two months following Merck's acquisition of Cubist. Cubicin sales for 2014 represent the previous licensing agreement in Japan prior to the acquisition.

(3) Includes Pharmaceutical products not individually shown above. Other Vaccines sales included in Other Pharmaceutical were $78 million, $76 million, $99 million, and $148 million for the first, second, third, and fourth quarters of 2015, respectively. Other Vaccines sales included in Other Pharmaceutical were $98 million, $76 million, $116 million and $88 million for the first, second, third and fourth quarters of 2014, respectively.

(4) On October 1, 2014, the company divested the Consumer Care business.

(5) Other revenues are comprised primarily of alliance revenue, third-party manufacturing sales and miscellaneous corporate revenues, including revenue hedging activities. On June 30, 2014, AstraZeneca exercised its option to buy Merck's interest in a subsidiary and through it, Merck's interest in Nexium and Prilosec. As a result, the company no longer records supply sales for these products. Other revenues in the first quarter 2014 include $232 million of revenue recognized in connection with the sale of U.S. Saphris rights.

 

   

Contact:

Merck
Media:
Lainie Keller, 908-236-5036
Steven Cragle, 908-740-1801
or
Investors:
Teri Loxam, 908-740-1986
Justin Holko, 908-740-1879

 

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