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United States Securities and Exchange Commission Form 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) February 5, 2020 Merck & Co., Inc. (Exact name of registrant as specified in its charter) New Jersey 1-6571 22-1918501 (State or other jurisdiction (Commission (IRS Employer of incorporation) File Number) Identification No.) 2000 Galloping Hill Road, Kenilworth, NJ 07033 (Address of principal executive offices) (Zip Code) Registrant’s telephone number, including area code (908) 740-4000 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: ¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ¨ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨ Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock ($0.50 par value) MRK New York Stock Exchange 1.125% Notes due 2021 MRK/21 New York Stock Exchange 0.500% Notes due 2024 MRK 24 New York Stock Exchange 1.875% Notes due 2026 MRK/26 New York Stock Exchange 2.500% Notes due 2034 MRK/34 New York Stock Exchange 1.375% Notes due 2036 MRK 36A New York Stock Exchange 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 Merck & Co., Inc. (the “Company”) on February 5, 2020, regarding earnings for the fourth quarter and year end of 2019, 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 8.01. Other Events. Incorporated by reference is a press release issued by the Company on February 5, 2020, regarding the spin-off of certain products into a new, independent, publicly-traded company. Item 9.01. Financial Statements and Exhibits. (d) Exhibits Exhibit 99.1 Press release issued February 5, 2020, regarding earnings for the fourth quarter and year end of 2019 Exhibit 99.2 Certain supplemental information not included in the press release Exhibit 99.3 Press release issued February 5, 2020, regarding the spin-off of certain products into a new, independent, publicly-traded company Exhibit 104 Cover Page Interactive Data File (embedded within the Inline XBRL document) SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Merck & Co., Inc. Date: February 5, 2020 By: /s/ Faye C. Brown FAYE C. BROWN Senior Assistant Secretary Exhibit 99.1 News Release FOR IMMEDIATE RELEASE Media Contacts: Jennifer Mauer Investor Contacts: Peter Dannenbaum (908) 740-1801 (908) 740-1037 Pamela Eisele Michael DeCarbo (267) 305-3558 (908) 740-1807 Merck Announces Fourth-Quarter and Full-Year 2019 Financial Results · Fourth-Quarter 2019 Worldwide Sales Were $11.9 Billion, an Increase of 8%; Excluding the Impact from Foreign Exchange, Sales Grew 9% · Fourth-Quarter 2019 GAAP EPS Was $0.92; Fourth-Quarter Non-GAAP EPS Was $1.16 · Full-Year 2019 Worldwide Sales Were $46.8 Billion, an Increase of 11%; Excluding the Impact from Foreign Exchange, Sales Grew 13% o KEYTRUDA 2019 Worldwide Sales Grew 55% to $11.1 Billion; Excluding the Impact from Foreign Exchange, Sales Grew 58% o Human Health Vaccines 2019 Worldwide Sales Grew 15% to $8.4 Billion; Excluding the Impact from Foreign Exchange, Sales Grew 17% o BRIDION 2019 Worldwide Sales Grew 23% to $1.1 Billion; Excluding the Impact from Foreign Exchange, Sales Grew 26% o Animal Health 2019 Worldwide Sales Grew 4% to $4.4 Billion; Excluding the Impact from Foreign Exchange, Sales Grew 9% · Full-Year 2019 GAAP EPS Was $3.81; Full-Year Non-GAAP EPS Was $5.19 · 2020 Financial Outlook o Anticipates Full-Year 2020 Worldwide Sales to Be Between $48.8 Billion and $50.3 Billion, Including a Negative Impact from Foreign Exchange of Less Than 1% o Expects Full-Year 2020 GAAP EPS to Be Between $4.57 and $4.72; Expects Non-GAAP EPS to Be Between $5.62 and $5.77, Including a Negative Impact from Foreign Exchange of Approximately 1.5% · In Conjunction with Fourth-Quarter Results, Merck Announces its Intention to Focus on Key Growth Pillars Through Spinoff of Women’s Health, Trusted Legacy Brands and Biosimilar Products into NewCo KENILWORTH, N.J., Feb. 5, 2020 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the fourth quarter and full year of 2019. “As evidenced by our results and our 2020 guidance, Merck had an extraordinary year and is in a position of operational and financial strength,” said Kenneth C. Frazier, chairman and chief executive officer, Merck. “It is this position of strength, born of our focused execution, that gives us the confidence to spin off our Women’s Health, trusted Legacy Brands and Biosimilar products into a new company, which will position us to deliver even greater value to patients and shareholders.” Financial Summary Fourth Quarter Year Ended Change Dec. 31, Dec. 31, Change $ in millions, except EPS amounts 2019 2018 Change Ex-Exchange 2019 2018 Change Ex-Exchange Sales $ 11,868 $ 10,998 8% 9% $ 46,840 $ 42,294 11% 13% GAAP net income1 2,357 1,827 29% 29% 9,843 6,220 58% 61% Non-GAAP net income that excludes certain items1,2* 2,978 2,745 8% 8% 13,382 11,621 15% 16% GAAP EPS 0.92 0.69 33% 32% 3.81 2.32 64% 67% Non-GAAP EPS that excludes certain items2* 1.16 1.04 12% 12% 5.19 4.34 20% 21% *Refer to table on page 10. GAAP (generally accepted accounting principles) earnings per share assuming dilution (EPS) was $0.92 for the fourth quarter and $3.81 for the full year of 2019. GAAP EPS for the full year of 2019 reflects a $993 million charge for the acquisition of Peloton Therapeutics, Inc. (Peloton) and a $612 million pretax intangible asset impairment charge related to SIVEXTRO (tedizolid phosphate). Non-GAAP EPS of $1.16 for the fourth quarter and $5.19 for the full year of 2019 excludes acquisition- and divestiture-related costs, restructuring costs and certain other items. Non-GAAP EPS for the full year of 2019 also excludes the charge for the acquisition of Peloton and the SIVEXTRO impairment charge. Oncology Pipeline Highlights Merck continued to advance the development programs for KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy; Lynparza (olaparib), a PARP inhibitor being co-developed and co-commercialized with AstraZeneca; and Lenvima (lenvatinib mesylate), an orally available tyrosine kinase inhibitor being co-developed and co-commercialized with Eisai Co., Ltd. (Eisai). · Merck announced the following regulatory milestones for KEYTRUDA: o Approval in the United States by the Food and Drug Administration (FDA) as monotherapy for the treatment of certain patients with high-risk, non- muscle invasive bladder cancer (NMIBC) based on the KEYNOTE-057 trial; o Approval in Japan for three new first-line indications across advanced renal cell carcinoma (RCC) based on the KEYNOTE-426 trial and recurrent or distant metastatic head and neck cancer based on the KEYNOTE-048 trial; o Approval in China for first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy based on the KEYNOTE-407 trial; and 1 Net income attributable to Merck & Co., Inc. 2 Merck is providing certain 2019 and 2018 non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing this information enhances investors’ understanding of the company’s results and permits investors to understand how management assesses performance. Management uses these measures internally for planning and forecasting purposes and to measure the performance of the company along with other metrics. Senior management’s annual compensation is derived in part using non-GAAP income and non-GAAP EPS. This information should be considered in addition to, but not as a substitute for or superior to, information prepared in accordance with GAAP.
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