Form 8-K Merck & Co. Inc. For: Oct 27

�

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C.� 20549

�

FORM�8-K

�

CURRENT REPORT

Pursuant to Section�13 or 15(d)�of

the Securities Exchange Act of 1934

�

Date of Report (Date of earliest event reported)�October�27, 2014

�

Merck�& Co.,�Inc.

(Exact Name of Registrant as Specified in Its Charter)

�

New Jersey

(State or Other Jurisdiction of Incorporation)

�

�

Registrant�s Telephone Number,�Including Area Code�(908) 423-1000

�

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

�

Check the appropriate box below if the Form�8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

�

o�� Written communications pursuant to Rule�425 under the Securities Act (17 CFR 230.425)

�

o����������� Soliciting material pursuant to Rule�14a-12 under the Exchange Act (17 CFR 240.14a-12)

�

o����������� Pre-commencement communications pursuant to Rule�14d-2(b)�under the Exchange Act (17 CFR 240.14d-2(b))

�

o����������� Pre-commencement communications pursuant to Rule�13e-4(c)�under the Exchange Act (17 CFR 240.13e-4(c))

�

�

�

Item 2.02.� Results of Operations and Financial Condition.

�

The following information, including the exhibits hereto, is being furnished pursuant to this Item 2.02.

�

Incorporated by reference is a press release issued by the Company on October�27, 2014, regarding earnings for the third quarter of 2014, attached as Exhibit�99.1.� Also incorporated by reference is certain supplemental information not included in the press release, attached as Exhibit�99.2.

�

This information shall not be deemed to be �filed� for purposes of Section�18 of the Securities Exchange Act of 1934, as amended (the �Exchange Act�), or otherwise subject to the liabilities of that Section, and is not incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

�

Item 9.01.� Financial Statements and Exhibits.

�

�

2

�

SIGNATURES

�

Pursuant to the requirements of the Securities Exchange Act of 1934, the Company has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

�

�

�

3

�

EXHIBIT�INDEX

�

�

4

Exhibit 99.1

�

�

�

Merck Announces Third-Quarter 2014 Financial Results

�

������������������ Third-Quarter 2014 Non-GAAP EPS of $0.90, Excluding Certain Items, and GAAP EPS of $0.31

�

������������������ Narrows 2014 Full-Year Non-GAAP EPS Target to $3.46 to $3.50, Excluding Certain Items; Updates 2014 Full-Year GAAP EPS Target to $4.06 to $4.29; Now Expects 2014 Full-Year Revenues to be Between $42.4 Billion and $42.8 Billion

�

������������������ Generated Worldwide Sales of $10.6 Billion, a Decrease of 4 Percent, Reflecting Unfavorable Impact of Divested Products, Patent Expiries and Decline in Sales of Hepatitis C Products

�

������������������ Increased Sales of Acute Care,�Immunology, Diabetes and Animal Health Products

�

������������������ FDA Approved KEYTRUDA for the Treatment of Advanced Melanoma in Patients Who Have Progressed after Other Therapies and BELSOMRA for the Treatment of Insomnia

�

������������������ KEYTRUDA Received Breakthrough Therapy Designation from the FDA for Patients with Advanced Non-Small Cell Lung Cancer Who Have Progressed Following Platinum-Containing Chemotherapy

�

WHITEHOUSE STATION, N.J., Oct.�27, 2014 � Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the third quarter of 2014.

�

�

1� Merck is providing certain 2014 and 2013 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 Table 2a, including the related footnotes, attached to this release.

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

�

�

Non-GAAP (generally accepted accounting principles) earnings per share (EPS) for the third quarter of $0.90 exclude acquisition- and divestiture-related costs, restructuring costs and certain other items.

�

A reconciliation of GAAP to non-GAAP net income and EPS is provided in the tables that follow. Year-to-date results can be found in the attached tables.

�

�

�Last October, we launched a multi-year initiative to transform Merck and build a platform for sustained, future growth,� said Kenneth C. Frazier, chairman and chief executive officer, Merck. �One year later, we delivered solid third-quarter results and are making steady progress in our transformation, including divesting non-core assets, reducing our expense base and investing in our promising new product launches and pipeline.�

�

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 of $1.0 billion and $1.2 billion in the third quarter of 2014 and 2013, respectively, for the amortization of intangible assets recognized as a result of mergers and acquisitions, as well as intangible asset impairment charges of $541 million in the third quarter of 2014. Also includes merger 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.

�

Page 2

�

Select Revenue Highlights

�

Worldwide sales were $10.6 billion for the third quarter of 2014, a decrease of 4 percent compared with the third quarter of 2013, including a 1 percent positive impact from foreign exchange. The decline includes $425 million of lower sales due to divestitures and the termination of the joint venture with AstraZeneca (AZ).

�

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

�

�

Pharmaceutical Revenue Performance

�

Third-quarter pharmaceutical sales declined 4 percent to $9.1 billion. Expected declines occurred due to the ongoing impact of product divestitures, as well as the loss of market exclusivity for certain products, including TEMODAR (temozolomide) and SINGULAIR (montelukast sodium). Also contributing to the decline were lower sales from the hepatitis franchise of VICTRELIS (boceprevir) and PEGINTRON (peginterferon alfa-2b) as a result of increased competition, as well as of GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]. These declines were partially offset by growth in the global acute care franchise, including NOXAFIL (posaconazole) and BRIDION (sugammadex); the diabetes franchise of JANUVIA (sitagliptin)/JANUMET (sitagliptin and metformin HCI); REMICADE (infliximab); SIMPONI (golimumab); and DULERA (mometasone furoate and formoterol fumarate dihydrate).

�

Combined sales of JANUVIA and JANUMET, medicines that help lower blood sugar levels in adults with type 2 diabetes, grew 5 percent to $1.4 billion in the third quarter. The growth reflects higher sales in the United States and Europe, which were partially offset by price reductions in Japan.

�

Page 3

�

Combined sales of ZETIA (ezetimibe) and VYTORIN (ezetimibe/simvastatin), medicines for lowering LDL cholesterol, declined 3 percent to $1.0 billion in the third quarter, driven by lower sales in the United States.

�

Combined sales of REMICADE and SIMPONI, treatments for inflammatory diseases, grew 11 percent to $774 million in the third quarter, including a 2 percent positive impact from foreign exchange. Over the last 12 months, SIMPONI has been the fastest growing anti-TNF agent in all countries where marketed by Merck.

�

Merck�s sales of GARDASIL, a vaccine to help prevent certain diseases caused by four types of human papillomavirus, were $590 million, a decrease of 11 percent for the third quarter. The results reflect lower purchases in the U.S. public sector.

�

Worldwide sales of ISENTRESS, an HIV integrase inhibitor for use in combination with other antiretroviral agents for the treatment of HIV-1 infection, decreased 3 percent to $412 million in the third quarter. The decline reflects lower sales in the United States, partially offset by growth in Europe.

�

On Sept. 4, 2014, the U.S. Food and Drug Administration (FDA) granted accelerated approval of KEYTRUDA (pembrolizumab), the first approved anti-PD-1 therapy in the United States. KEYTRUDA has been approved for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Within a few days of approval, initial orders shipped, and the Merck team has already reached more than 75 percent of key physicians. Merck believes there are currently approximately 1,200 patients who may be eligible for KEYTRUDA, based on the product�s label, and to date, approximately 900 patients are being treated with KEYTRUDA.

�

Animal Health Revenue Performance

�

Animal Health sales totaled $885 million for the third quarter of 2014, an increase of 11 percent compared with the third quarter of 2013, including a 1 percent positive impact due to foreign exchange. Growth was driven by increases across all species. In companion animals, growth was supported by ongoing launches in Europe and the United States of BRAVECTO (fluralaner), a chewable tablet that kills fleas and ticks in dogs for up to 12 weeks. Growth was partially offset by the loss of sales of ZILMAX (zilpaterol hydrochloride), a feed supplement for beef cattle. The company decided last year to voluntarily suspend sales of ZILMAX in the United States and Canada. Excluding the impact of the ZILMAX sales suspension, Animal Health sales increased 14 percent in the third quarter.

�

Page 4

�

Consumer Care Revenue Performance

�

Third-quarter global sales of Consumer Care products were $401 million, a decline of 9 percent compared to the third quarter of 2013. As previously announced, Merck completed the sale of its Consumer Care business to Bayer AG on Oct.�1, 2014.

�

Other Revenue Performance

�

Other revenues � primarily comprising alliance revenue, miscellaneous corporate revenues and third-party manufacturing sales � decreased 56 percent to $137 million compared to the third quarter of 2013. The decrease was driven primarily by the loss of revenue from AZ recorded by Merck, which was $220 million in the third quarter of 2013. On June�30, 2014, AZ exercised its option to buy the company�s interest in a subsidiary and, through it, the company�s interest in Nexium and Prilosec. As of July�1, 2014, Merck no longer records equity income from AZ and supply sales to AZ have ended. The decline in other revenues also reflects $50 million of lower third-party manufacturing sales, primarily driven by the divestiture of a substantial portion of this business in 2013.

�

Third-Quarter Expense and Other Information

�

The costs detailed below totaled $9.2 billion on a GAAP basis during the third quarter of 2014 and include $2.4 billion of acquisition- and divestiture-related costs, restructuring costs and certain other items.

�

�

Page 5

�

The gross margin was 60.0 percent for the third quarter of 2014 compared to 62.8 percent for the third quarter of 2013, reflecting 14.3 and 11.2 unfavorable percentage point impacts, respectively, from the acquisition- and divestiture-related costs, and restructuring costs noted above.

�

Marketing and administrative expenses, on a non-GAAP basis, were $2.6 billion in the third quarter of 2014, a decrease primarily due to productivity measures from $2.8 billion in the same period of 2013.

�

Research and development (R&D) expenses, on a non-GAAP basis, were $1.5 billion in the third quarter of 2014, a decrease from $1.7 billion in the third quarter of 2013. The decline reflects targeted cost reductions and lower clinical development spending resulting from portfolio prioritization.

�

Other (income) expense, net, was $142 million of income in the third quarter of 2014 compared to $172 million of expense in the third quarter of 2013. The third quarter of 2014 includes a gain of $396 million on the divestiture of certain ophthalmic products in several international markets, partially offset by a $93 million goodwill impairment charge related to the company�s joint venture with Supera Farma Laboratorios S.A. in Brazil.

�

The GAAP effective tax rate of 43.5 percent for the third quarter of 2014 reflects the impacts of acquisition- and divestiture-related costs, restructuring costs and certain other items, including an additional year of expense related to the non-tax deductible health care reform fee. The non-GAAP effective tax rate, which excludes these items, was 26.5 percent for the quarter.

�

Key Developments

�

������������������ The FDA granted accelerated approval of KEYTRUDA on Sept. 4, 2014, for the treatment of advanced melanoma in patients who have progressed after other therapies.

�

������������������ As announced earlier today, KEYTRUDA received Breakthrough Therapy Designation from the FDA for patients with advanced non-small cell lung cancer who have progressed following platinum-containing chemotherapy.

�

������������������ Interim data in five tumor types exploring investigational uses of KEYTRUDA was presented at the 2014 European Society for Medical Oncology 2014 Congress.

�

������������������ On Aug.�13, 2014, the FDA approved BELSOMRA (suvorexant) for the treatment of adults with insomnia who have difficulty falling asleep and/or staying asleep.

�

������������������ Merck completed the sale of its Consumer Care business to Bayer AG on Oct.�1, 2014. As previously announced, the companies have entered into a worldwide collaboration to develop and commercialize soluble guanylate cyclase modulators. The collaboration includes Bayer�s Adempas (riociguat), which is approved to treat pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension.

�

Page 6

�

������������������ On Aug.�5, 2014, Merck completed its acquisition of Idenix Pharmaceuticals,�Inc. to expand its portfolio of investigational therapies for hepatitis C.

�

������������������ On Oct.�15, 2014, the company announced that it accepted for purchase $1.8 billion in principal amount of eight series of notes as part of a previously announced tender offer. In addition, the company intends to redeem its $1.0 billion 4% Notes due 2015 and its $1.0 billion 6% Senior Notes due 2017. As a result of these transactions, Merck expects to record a pre-tax charge of approximately $650 million in the fourth quarter of 2014, which will be excluded from non-GAAP results.

�

For a full listing of company developments that occurred in the third quarter of 2014, visit the newsroom at www.merck.com.

�

Financial Outlook

�

Merck has narrowed its full-year 2014 non-GAAP EPS range to be between $3.46 and $3.50. The range excludes acquisition- and divestiture-related costs and costs related to restructuring programs, as well as certain other items. Merck now expects the company�s full-year 2014 GAAP EPS range to be between $4.06 and $4.29.

�

At current exchange rates, Merck now anticipates full-year 2014 revenues to be between $42.4 billion and $42.8 billion.

�

In addition, the company continues to expect full-year 2014 non-GAAP marketing and administrative and R&D expenses will be below 2013 levels. In the fourth quarter of 2014, the company anticipates R&D expenses will be higher than the fourth quarter of 2013 due to timing of certain programs. The company continues to anticipate its full-year 2014 non-GAAP tax rate will be in the range of 24 to 26 percent, not including a 2014 R&D tax credit.

�

A reconciliation of anticipated 2014 EPS, as reported in accordance with GAAP to non-GAAP EPS that excludes certain items, is provided in the table below.

�

�

Page 7

�

Total Employees

�

As of Sept. 30, 2014, Merck had approximately 71,000 employees worldwide. In addition, the company�s joint ventures in China and Brazil, which are included in the consolidated results of Merck, had about 1,200 employees.

�

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://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 5243903. Members of the media are invited to monitor the call by dialing (706) 758-9928 or (800) 399-7917 and using ID code number 5243903. 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 healthcare 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 healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube. You can also follow our Twitter conversation at $MRK.

�

Forward-Looking Statement

�

This news release includes �forward-looking statements� within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck�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

�

Page 8

�

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; Merck�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 Merck�s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

�

Merck 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 Merck�s 2013 Annual Report on Form�10-K and the company�s other filings with the Securities and Exchange Commission (SEC) available at the SEC�s Internet site (www.sec.gov).

�

###

�

Page 9

�

MERCK�& CO.,�INC.

CONSOLIDATED STATEMENT OF INCOME - GAAP

(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)

(UNAUDITED)

Table 1

�

�

* 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)�Reflects the performance of the company�s joint ventures and other equity method affiliates, including the Sanofi Pasteur MSD partnership, as well as the AstraZeneca LP partnership until its termination on June�30, 2014.

�

(4)�Other (income) expense, net in the third quarter and first nine months of 2014 includes a gain of $396 million on the divestiture of certain ophthalmic products in several international markets, partially offset by a $93 million goodwill impairment charge related to the company�s joint venture with Supera Farma Laboratorios S.A. Other (income) expense, net in the first nine months of 2014 also includes a gain of $741 million related to AstraZeneca�s option exercise and net gains of $168 million related to the divestiture of the company�s Sirna Therapeutics,�Inc. subsidiary. Other (income) expense, net in the first nine months of 2013 reflects approximately $140 million of exchange losses as a result of a Venezuelan currency devaluation.

�

(5) The effective income tax rate for the first nine months 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.

�

The effective income tax rate for the first nine months of 2013 reflects net benefits from the settlements of certain federal income tax issues, reductions in tax reserves upon expiration of applicable statute of limitations and the favorable impact of tax legislation enacted in the first quarter of 2013.

�

�

MERCK�& CO.,�INC.

CONSOLIDATED STATEMENT OF INCOME

GAAP TO NON-GAAP RECONCILIATION

THIRD QUARTER 2014

(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)

(UNAUDITED)

Table 2a

�

�

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 expenses of $1.0 billion for the amortization of intangible assets recognized as a result of mergers and acquisitions, as well as $412 million of impairment charges on product intangibles. Amounts included in marketing and administrative expenses reflect merger integration costs, as well as transaction and certain other costs related to business acquisitions and divestitures. Amounts included in research and development expenses represent in-process research and development (�IPR&D�) impairment charges primarily related to the company�s joint venture with Supera. Amount included in other (income) expense, net represents a goodwill impairment charge related to the joint venture with Supera. Amount included in net (loss) income attributable to non-controlling interests represents the portion of intangible asset and goodwill impairment charges related to the joint venture with Supera that are attributable to non-controlling interests.

�

(2)�Amounts primarily include employee separation costs and accelerated depreciation associated with facilities to be closed or divested related to actions under the company�s formal restructuring programs.

�

(3)�Amount included in marketing and administrative expenses represents an additional year of expense related to the healthcare reform fee in accordance with final regulations issued in the third quarter by the Internal Revenue Service. Included in other (income) expenese, net is a $396 million gain on the divestiture of certain ophthalmic products in several international markets.

�

(4)�Represents the estimated tax impact on the reconciling items.

�

�

MERCK�& CO.,�INC.

CONSOLIDATED STATEMENT OF INCOME

GAAP TO NON-GAAP RECONCILIATION

NINE MONTHS ENDED SEPTEMBER 30, 2014

(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)

(UNAUDITED)

Table 2b

�

�

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 expenses of $3.2 billion for the amortization of intangible assets recognized as a result of mergers and acquisitions, as well as $1.1 billion of impairment charges on product intangibles. Amounts included in marketing and administrative expenses reflect merger integration costs, as well as transaction and certain other costs related to business acquisitions and divestitures. Amounts included in research and development expenses represent in-process research and development (�IPR&D�) impairment charges primarily related to the company�s joint venture with Supera. Amount included in other (income) expense, net is a goodwill impairment charge related to the joint venture with Supera. Amount included in net income (loss) attributable to non-controlling interests represents the portion of intangible asset and goodwill impairment charges related to the joint venture with Supera that are attributable to non-controlling interests.

�

(2)�Amounts primarily include employee separation costs and accelerated depreciation associated with facilities to be closed or divested related to actions under the company�s formal restructuring programs.

�

(3)�Amount included in marketing and administrative expenses represents an additional year of expense related to the healthcare reform fee in accordance with final regulations issued in the third quarter by the Internal Revenue Service. Included in other (income) expense, net is a $396 million gain on the divestiture of certain ophthalmic products in several international markets and a $741 million net gain related to AstraZeneca�s option exercise.

�

(4)�Represents the estimated tax impact on the reconciling items, including a net benefit of approximately $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.

�

�

MERCK�& CO.,�INC.

FRANCHISE / KEY PRODUCT SALES

(AMOUNTS IN MILLIONS)

Table 3

�