8-K

Merck & Co., Inc. (MRK)

8-K 2020-10-27 For: 2020-10-27
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Added on April 02, 2026

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, 2020

Merck & Co., Inc.

(Exact name of registrant as specified in its charter)

New Jersey<br> <br>(State or other jurisdiction<br> <br>of incorporation) 1-6571<br> <br>(Commission<br> <br>File Number) 22-1918501<br> <br>(I.R.S Employer<br> <br>Identification No.)

2000 Galloping Hill Road, Kenilworth, NJ<br> <br>(Address of principal executive offices) 07033<br> <br>(Zip Code)

(Registrant’s telephone number, including area code)

(908) 740-4000

Not Applicable

(Former name, former address and former fiscal year, 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 October 27, 2020, regarding earnings for the third quarter of 2020, 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.

(d)    Exhibits

Exhibit 99.1 Press release issued October 27, 2020, regarding earnings for the third quarter of 2020
Exhibit 99.2 Certain supplemental information not included in the press release
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: October 27, 2020 By: /s/ Kelly Grez
KELLY GREZ
Deputy Corporate Secretary

Exhibit 99.1

News<br> Release

FOR IMMEDIATE RELEASE

Media Contacts: Pamela Eisele Investor Contacts: Peter Dannenbaum
(267) 305-3558 (908) 740-1037
Patrick Ryan Michael DeCarbo
(201) 452-2409 (908) 740-1807

Merck Announces Third-Quarter 2020 FinancialResults


· Third-Quarter 2020 Worldwide Sales Were $12.6 Billion, an Increase<br>of 1%; Excluding the Impact from Foreign Exchange, Sales Grew 2%
o KEYTRUDA Sales Grew 21% to $3.7 Billion
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o Animal Health Sales Grew 9% to $1.2 Billion; Excluding the Impact from Foreign Exchange, Sales Grew 12%
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· Third-Quarter 2020 GAAP EPS Was $1.16; Third-Quarter Non-GAAP EPS<br>Was $1.74
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· Advanced and Expanded Broad Pipeline
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o Announced Additional Positive Phase 3 Results for Investigational Pneumococcal Conjugate Vaccine (V114) in Adults
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o Presented Phase 3 Data for Investigational Gefapixant in Development for Chronic Cough; Early Data for MK-4830 in Oncology<br>and MK-8507 for HIV
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o Expanded Pipeline with Seagen Collaborations in Oncology
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· Company Advances Research Programs and Clinical Trials for COVID-19-Related<br>Vaccine and Orally Available Antiviral Research Candidates
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· Company Narrows and Raises 2020 Full-Year Revenue Range to be Between<br>$47.6 Billion and $48.6 Billion, Including a Negative Impact from Foreign Exchange of Approximately 1.5%
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· Company Narrows and Lowers 2020 Full-Year GAAP EPS<br>Range to be Between $4.55 and $4.65; Narrows and Raises 2020 Full-Year Non-GAAP EPS Range to be Between $5.91 and $6.01, Including<br>a Negative Impact from Foreign Exchange of Approximately 2.5%
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KENILWORTH, N.J., Oct. 27, 2020 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the third quarter of 2020.

“We continue to execute on our strategic priorities and remain confident we will achieve solid full-year revenue growth despite the impact of the ongoing COVID-19 pandemic. Demand for our products remains robust, and production, supply and distribution of our medicines, vaccines and animal health products are moving forward with minimal disruption,” said Kenneth C. Frazier, chairman and chief executive officer, Merck. “I am confident in our ability to advance our promising pipeline and clinical trials despite the challenging environment, and I believe that our leadership and track record of solid commercial execution will continue to drive long-term growth.”

Financial Summary

Third Quarter
$ in millions, except EPS amounts 2020 2019 Change Change Ex-<br> Exchange
Sales $ 12,551 $ 12,397 1 % 2 %
GAAP net income^1^ 2,941 1,901 55 % 59 %
Non-GAAP<br> net income that excludes certain items^1,2*^ 4,427 3,873 14 % 17 %
GAAP EPS 1.16 0.74 57 % 62 %
Non-GAAP<br> EPS that excludes certain items^2*^ 1.74 1.51 16 % 18 %

*Refer to table on page 11.

GAAP (generally accepted accounting principles) earnings per share assuming dilution (EPS) was $1.16 for the third quarter of 2020. Non-GAAP EPS of $1.74 for the third quarter of 2020 excludes acquisition- and divestiture-related costs, restructuring costs, pretax charges of $1.1 billion related to certain license and collaboration agreements, and certain other items. Year-to-date results can be found in the attached tables.


COVID-19 Research Highlights

Building on the company’s experience with antivirals and vaccines, Merck advanced its multiple scientific programs in an effort to help combat SARS-CoV-2, specifically,

· Molnupiravir (formerly known as MK-4482) -- an orally available<br>antiviral candidate in development for the treatment of COVID-19 in collaboration with Ridgeback Bio with the initiation of two<br>large pivotal Phase 2/3 trials: a trial anticipated to enroll approximately 1,450 non-hospitalized adult COVID-19 patients (outpatient)<br>and another planned to enroll approximately 1,300 hospitalized adult COVID-19 patients;
· V591 -- a SARS-CoV-2 vaccine candidate that uses a measles<br>virus vector platform has entered Phase 1 development; and
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· V590 -- a SARS-CoV-2 vaccine candidate in development in collaboration<br>with the International AIDS Vaccine Initiative (IAVI) that uses a recombinant vesicular stomatitis virus (rVSV) platform, the same<br>platform used for Merck’s approved Ebola Zaire virus vaccine, will enter Phase 1 development shortly.
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^1^ Net income attributable to Merck & Co., Inc.
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^2^ Merck is providing certain 2020 and 2019 non-GAAP information<br>that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business<br>performance and trends. Management believes that providing this information enhances investors’ understanding of the company’s<br>results and permits investors to understand how management assesses performance. Management uses these measures internally for<br>planning and forecasting purposes and to measure the performance of the company along with other metrics. In addition, senior<br>management’s annual compensation is derived in part using non-GAAP pretax income. This information should be considered<br>in addition to, but not as a substitute for or superior to, information prepared in accordance with GAAP. For a description of<br>the items, see Table 2a attached to this release.
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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), in addition to other notable developments as follows:

· Merck announced the following regulatory milestones for KEYTRUDA:
o Approval in the United States by the Food and Drug Administration (FDA) of an expanded indication as monotherapy for the treatment<br>of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) based on the Phase 3 KEYNOTE-204 trial and an updated<br>pediatric indication for the treatment of pediatric patients with refractory cHL or cHL that has relapsed after two or more lines<br>of therapy, both of which were previously approved under the FDA’s accelerated approval process; and
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o Two approvals in Japan: (1) as monotherapy for the treatment of patients whose tumors are PD-L1-positive and have radically<br>unresectable, advanced or recurrent esophageal squamous cell carcinoma (ESCC) who have progressed after chemotherapy based on the<br>KEYNOTE-181 trial; and (2) use at an additional recommended dosage of 400 mg every six weeks (Q6W) administered as an intravenous<br>infusion over 30 minutes across all adult indications, including KEYTRUDA monotherapy and combination therapy.
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· Merck presented results from the pivotal Phase 3 KEYNOTE-590 trial<br>for the first-line treatment of patients with locally advanced or metastatic esophageal and gastroesophageal junction (GEJ) cancer<br>at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. In the study, KEYTRUDA in combination with platinum-based<br>chemotherapy (cisplatin plus 5-fluorouracil [5-FU]) significantly improved overall survival (OS) and progression-free survival<br>(PFS) versus chemotherapy regardless of histology or PD-L1 expression status.
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· Merck presented five-year survival results from the pivotal Phase<br>3 KEYNOTE-024 trial at the ESMO Virtual Congress 2020, which demonstrated a sustained, long-term survival benefit and durable responses<br>with KEYTRUDA versus chemotherapy as a first-line treatment in patients with metastatic non-small cell lung cancer (NSCLC) whose<br>tumors express PD-L1 (tumor proportion score [TPS] ≥50%) with no EGFR or ALK genomic tumor aberrations. Results from KEYNOTE-024<br>represent the longest follow-up survival data for an immunotherapy in a randomized Phase 3 study for the first-line treatment of<br>metastatic NSCLC.
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· Merck presented long-term findings from the EORTC1325/KEYNOTE-054<br>trial evaluating KEYTRUDA as adjuvant therapy in resected, high-risk stage III melanoma at the ESMO Virtual Congress 2020.
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· Merck presented three-year survival data from the KEYNOTE-021<br> (Cohort G) study that evaluated KEYTRUDA in combination with chemotherapy in patients with advanced nonsquamous NSCLC<br> regardless of PD-L1 expression with no EGFR or ALK genomic tumor aberrations at the IASLC 2020 North America Conference<br> on Lung Cancer (NACLC). Updated follow-up data from a Phase 1/2 study of quavonlimab<br>(MK-1308), a novel investigational anti-CTLA-4 antibody, in combination with KEYTRUDA in patients with advanced NSCLC also was<br>presented; a Phase 3 study of quavonlimab coformulated with KEYTRUDA in first-line advanced NSCLC is planned.
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· Merck and AstraZeneca announced the adoption of two positive opinions<br>by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for Lynparza:
o As a first-line maintenance treatment with bevacizumab for homologous recombination deficient (HRD)-positive advanced ovarian<br>cancer who are in complete or partial response following completion of first-line platinum-based chemotherapy in combination with<br>bevacizumab based on the Phase 3 PAOLA-1 trial, and
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o As monotherapy for the treatment of BRCA1/2 metastatic castration-resistant prostate cancer (mCRPC) patients who have<br>progressed following a prior therapy that included a new hormonal agent based on the Phase 3 PROfound trial. Final results from<br>this study were recently presented at the ESMO Virtual Congress 2020.
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· Merck and AstraZeneca presented positive five-year follow-up data<br>from the Phase 3 SOLO-1 trial, which demonstrated a long-term PFS benefit of Lynparza versus placebo as a first-line maintenance<br>treatment in patients with newly diagnosed, advanced BRCA-mutated (BRCAm) ovarian cancer who were in complete or<br>partial response to platinum-based chemotherapy.
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· Merck and Eisai presented first-time data from two studies evaluating<br>KEYTRUDA plus Lenvima at the ESMO Virtual Congress 2020: data from the Phase 2 LEAP-004 study for the second-line treatment of<br>patients with unresectable or advanced melanoma who progressed on anti-PD-1/PD-L1 therapy and from the Phase 2 LEAP-005 study in<br>previously-treated patients with six tumor types, including biliary tract cancer, colorectal cancer, gastric cancer, glioblastoma<br>multiforme, ovarian cancer and triple-negative breast cancer.
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· Merck also presented new data for three investigational medicines<br>from its oncology pipeline at the ESMO Virtual Congress 2020:
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o New Phase 1 data for the company’s anti-TIGIT therapy vibostolimab (MK-7684) as monotherapy and in combination with KEYTRUDA<br>in patients with metastatic NSCLC,
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o First-time Phase 1 results for the novel anti-immunoglobulin-like transcript 4 (ILT4) therapy MK-4830 in patients with advanced<br>solid tumors, and
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o New Phase 2 data evaluating the hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor MK-6482 in von Hippel-Lindau (VHL)<br>patients with non-renal cell carcinoma (RCC) tumors and updated data in VHL patients with clear cell RCC.
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Other Pipeline Highlights

· Merck announced that two Phase 3 adult studies [the pivotal PNEU-AGE<br>trial (V114-019) as well as the PNEU-TRUE trial (V114-020)] and separately two other Phase 3 adult studies [the PNEU-PATH (V114-016)<br>and PNEU-DAY (V114-017) trials], evaluating the safety, tolerability and immunogenicity of V114, the company’s investigational<br>15-valent pneumococcal conjugate vaccine, each met their primary immunogenicity objectives. These findings, and additional Phase<br>3 data from the clinical program, will form the basis of global regulatory licensure applications beginning with the FDA before<br>the end of the year.
· Merck presented results from two pivotal Phase 3 trials (COUGH-1 and<br>COUGH-2) evaluating gefapixant, an investigational, orally administered selective P2X3 receptor antagonist, in which gefapixant<br>45 mg twice daily demonstrated a statistically significant reduction in 24-hour cough frequency compared to placebo at Week 12<br>and 24 in adult patients with refractory or unexplained chronic cough. The gefapixant 15 mg twice daily treatment arms did not<br>meet the primary efficacy endpoint in either Phase 3 study. The results were presented at the Virtual European Respiratory Society<br>(ERS) International Congress 2020.
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· Merck presented Week 96 data from the Phase 2b trial that showed islatravir,<br>the company’s investigational oral nucleoside reverse transcriptase translocation inhibitor (NRTTI), in combination with<br>doravirine (PIFELTRO), maintained viral suppression in treatment-naïve adults with HIV-1 infection. Also presented at the<br>virtual 2020 International Congress on Drug Therapy in HIV Infection (HIV Glasgow 2020 Virtual) were results from Phase 1/1b studies<br>for MK-8507, the company’s investigational once-weekly, oral non-nucleoside reverse transcriptase inhibitor (NNRTI), that<br>support further investigation for once-weekly oral administration as part of combination antiretroviral therapy.
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· The FDA has granted V181, the company’s investigational dengue<br>vaccine in Phase 1 development, Fast Track designation.
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Business Developments


· Merck and Seagen Inc. (formerly known as Seattle Genetics, Inc.) announced<br>two strategic oncology collaborations, in which Merck will make $810 million of upfront payments in the aggregate as well as acquire<br>a $1 billion equity stake in Seagen common stock:
o Companies to co-develop and co-commercialize Seagen’s ladiratuzumab vedotin, an investigational antibody-drug conjugate<br>targeting LIV-1, globally; and
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o Companies enter into exclusive license and co-development agreement to accelerate global reach of Tukysa (tucatinib), a small<br>molecule tyrosine kinase inhibitor for the treatment of HER-2 positive cancers. Merck was granted an exclusive license to commercialize<br>Tukysa in Asia, the Middle East and Latin America and other regions outside of the U.S., Canada and Europe.
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· Merck and Hanmi Pharmaceutical announced that the companies have entered<br>into an exclusive licensing agreement for the development, manufacture and commercialization of efinopegdutide (formerly HM12525A),<br>Hanmi’s investigational once-weekly glucagon-like peptide-1 (GLP-1)/glucagon receptor dual agonist, for the treatment of<br>nonalcoholic steatohepatitis (NASH);
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· Merck announced the completion of its acquisition of IdentiGEN, a<br>leader in DNA-based animal traceability solutions for livestock and aquaculture; and
· Merck announced the completion of its acquisition of the worldwide<br>rights to VECOXAN (diclazuril), an oral suspension for the prevention of coccidiosis in calves and lambs.
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Organon & Co.

· Merck continued to make progress on the Organon & Co. (Organon)<br>spinoff, including additional leadership appointments, and expects the transaction to be completed in the second quarter of 2021.

Third-Quarter Financial Impact ofCOVID-19

In the third quarter, the estimated negative impact of the COVID-19 pandemic to Merck’s pharmaceutical revenue was approximately $475 million, bringing the company’s year-to-date negative impact on revenue to approximately $2.1 billion. Lower back-to-school demand negatively impacted vaccine sales, in particular GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) in the U.S. In addition, access to health care providers remains reduced, although improved from the second quarter. The negative impact to Animal Health sales in the third quarter was immaterial.

Operating expenses were positively impacted in the third quarter by approximately $115 million, primarily driven by lower promotional and selling costs as well as lower research and development (R&D) expenses, net of investments in COVID-19-related antiviral and vaccine research programs.

Third-Quarter Revenue Performance

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

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Third Quarter
$<br>in millions **** 2020 **** 2019 **** Change Change Ex-<br><br>Exchange
Total Sales $ 12,551 $ 12,397 1 % 2 %
Pharmaceutical 11,320 11,095 2 % 2 %
KEYTRUDA 3,715 3,070 21 % 21 %
JANUVIA / JANUMET 1,327 1,311 1 % 2 %
GARDASIL / GARDASIL 9 1,187 1,320 -10 % -10 %
PROQUAD, M-M-R II and VARIVAX 576 623 -8 % -7 %
PNEUMOVAX 23 375 237 58 % 58 %
BRIDION 320 284 13 % 13 %
ROTATEQ 210 180 16 % 17 %
SIMPONI 209 203 3 % 0 %
ISENTRESS / ISENTRESS HD 205 250 -18 % -18 %
Lynparza* 196 123 59 % 58 %
IMPLANON / NEXPLANON 189 199 -5 % -4 %
Lenvima* 142 109 30 % 29 %
Animal Health 1,220 1,122 9 % 12 %
Livestock 758 726 5 % 8 %
Companion Animals 462 396 17 % 18 %
Other Revenues** 11 180 -94 % -33 %

*Alliance revenue for these products represents Merck’s share of profits, which are product sales net of cost of sales and commercialization costs.

**Other revenues are comprised primarily of third-party manufacturing sales and miscellaneous corporate revenues, including revenue hedging activities.


Pharmaceutical Revenue

Third-quarter pharmaceutical sales increased by $225 million, or 2%, to $11.3 billion. The increase was driven primarily by growth in oncology and certain hospital acute care products, partially offset by the negative impact of the COVID-19 pandemic and the ongoing impacts of the loss of market exclusivity for several products.

Growth in oncology was largely driven by higher sales of KEYTRUDA, which grew 21% to $3.7 billion in the quarter. In the U.S., sales of KEYTRUDA grew 24% to $2.2 billion. Global sales growth of KEYTRUDA reflects continued strong momentum from the NSCLC indications as well as continued uptake in other indications, including adjuvant melanoma, RCC, bladder, head and neck squamous cell carcinoma (HNSCC) and microsatellite instability-high (MSI-H) cancers as well as uptake following the recent launch of the Q6W dosing regimen in the U.S., partially offset by the negative impacts of the COVID-19 pandemic and pricing in Japan. Also contributing to growth in oncology was higher alliance revenue related to Lynparza and Lenvima reflecting continued uptake in approved indications in the U.S., Europe and China.

Performance in hospital acute care reflects higher demand globally for BRIDION (sugammadex), a medicine for the reversal of neuromuscular blockade induced by rocuronium bromide or vecuronium bromide in adults undergoing surgery and the ongoing launch of PREVYMIS (letermovir), a medicine for prophylaxis (prevention) of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant.

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In addition, sales of JANUVIA (sitagliptin) and JANUMET (sitagliptin and metformin HCI) increased slightly in the quarter reflecting strong demand from certain international markets, partially offset by continued pricing pressure in the U.S.

Vaccine sales performance reflects higher sales of PNEUMOVAX 23 (pneumococcal vaccine polyvalent), a vaccine to help prevent pneumococcal disease, primarily driven by higher volumes in the U.S., Europe and Japan attributable in part to increased demand for pneumococcal vaccination during the COVID-19 pandemic.

Vaccine sales were negatively affected by declines in sales of GARDASIL [Human Papillomavirus Quadrivalent (Types 6,11,16 and 18) Vaccine, Recombinant]/GARDASIL 9, vaccines to prevent certain cancers and other diseases caused by HPV, largely due to lower demand in the U.S. and Hong Kong, SAR, PRC attributable to the COVID-19 pandemic, partially offset by higher volumes in China and in Europe.

Combined sales of pediatric vaccines VARIVAX (Varicella Virus Vaccine Live), a vaccine to help prevent chickenpox; PROQUAD (Measles, Mumps, Rubella and Varicella Virus Vaccine Live), a combination vaccine to help protect against measles, mumps, rubella and varicella; and M-M-R II (Measles, Mumps and Rubella Virus Vaccine Live), a vaccine to help prevent measles, mumps and rubella, declined in the third quarter, primarily due to lower demand in the U.S. related to the COVID-19 pandemic.

Pharmaceutical sales in the quarter were negatively affected by the ongoing impacts from the loss of market exclusivity, including for NUVARING (etonogestrel/ethinyl estradiol vaginal ring), NOXAFIL (posaconazole) and EMEND (aprepitant)/EMEND (fosaprepitant dimeglumine) for Injection.


AnimalHealth Revenue

Animal Health sales totaled $1.2 billion in the third quarter of 2020, an increase of 9% compared with the third quarter of 2019; excluding the unfavorable effect from foreign exchange, Animal Health sales grew 12%. Growth in companion animal products was driven largely by higher demand in companion animal vaccines and higher demand for the BRAVECTO (fluralaner) line of products for parasitic control. Performance in livestock products reflects higher demand globally for ruminant, poultry and swine products.


Third-QuarterExpense, EPS and Related Information

The tables below present selected expense information.

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$<br> in millions <br><br><br><br>GAAP Acquisition- and Divestiture-Related Costs^3^ ****<br><br>Restructuring Costs ****<br><br>Certain Other Items <br><br><br><br>Non-GAAP^2^
Third-Quarter 2020
Cost<br> of sales $ 3,481 $ 285 $ 38 $ $ 3,158
Selling,<br> general and administrative 2,450 207 15 2,228
Research<br> and development 3,390 16 19 1,082 2,273
Restructuring<br> costs 114 114
Other<br> (income) expense, net (312 ) (1 ) (311 )
Third-Quarter<br> 2019
Cost<br> of sales $ 3,990 $ 941 $ 62 $ $ 2,987
Selling,<br> general and administrative 2,589 22 1 2,566
Research<br> and development 3,204 6 1 982 2,215
Restructuring<br> costs 232 232
Other<br> (income) expense, net 35 6 29

GAAPExpense, EPS and Related Information

Gross margin was 72.3% for the third quarter of 2020 compared to 67.8% for the third quarter of 2019. The increase reflects lower acquisition- and divestiture-related costs and the favorable effect of product mix, partially offset by the unfavorable effects of pricing pressure, inventory write-offs, higher amortization of intangible assets related to collaborations and foreign exchange.

Selling, general and administrative expenses were $2.5 billion in the third quarter of 2020, a decrease of 5% compared to the third quarter of 2019. The decrease primarily reflects lower administrative and selling costs, including less travel and meeting expenses, due in part to the COVID-19 pandemic, partially offset by higher acquisition- and divestiture-related costs, primarily reflecting costs related to the company’s planned spinoff of Organon.

Research and development expenses were $3.4 billion in the third quarter of 2020, an increase of 6% compared with the third quarter of 2019. The increase was primarily driven by higher upfront payments related to collaborations and license agreements, higher expenses related to clinical development and increased investment in discovery research and early drug development, partially offset by lower charges for the acquisitions of businesses, as well as lower laboratory, travel and meeting expenses due to the COVID-19 pandemic.

Other (income) expense, net, was $312 million of income in the third quarter of 2020 compared to $35 million of expense in the third quarter of 2019, primarily due to higher income from investments in equity securities, net, which was $360 million in 2020 compared with $16 million in 2019, largely from the recognition of unrealized gains on securities.

^3^ Includes<br>expenses for the amortization of intangible assets and purchase accounting adjustments to inventories recognized as a result of<br>acquisitions, intangible asset impairment charges, and expense or income related to changes in the estimated fair value measurement<br>of liabilities for contingent consideration. Also includes integration, transaction and certain other costs related to business<br>acquisitions and divestitures.
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The effective income tax rate was 14.1% for the third quarter of 2020 compared to 18.7% in the third quarter of 2019. The effective income tax rate in 2019 reflects the unfavorable impact of a charge for the acquisition of Peloton Therapeutics, Inc. (Peloton) for which no tax benefit was recognized.

GAAP EPS was $1.16 for the third quarter of 2020 compared with $0.74 for the third quarter of 2019.

Non-GAAPExpense, EPS and Related Information

Non-GAAP gross margin was 74.8% for the third quarter of 2020 compared to 75.9% for the third quarter of 2019. The decrease in non-GAAP gross margin reflects the unfavorable effects of pricing pressure, inventory write-offs, higher amortization of intangible assets related to collaborations and foreign exchange, partially offset by the favorable effect of product mix.

Non-GAAP selling, general and administrative expenses were $2.2 billion in the third quarter of 2020, a decrease of 13% compared to the third quarter of 2019. The decrease primarily reflects lower administrative and selling costs, including less travel and meeting expenses, due in part to the COVID-19 pandemic.

Non-GAAP R&D expenses were $2.3 billion in the third quarter of 2020, a 3% increase compared to the third quarter of 2019. The increase was primarily driven by higher expenses related to clinical development and increased investment in discovery research and early drug development, partially offset by lower laboratory, travel and meeting expenses due to the COVID-19 pandemic.

Non-GAAP other (income) expense, net, was $311 million of income in the third quarter of 2020 compared to $29 million of expense in the third quarter of 2019, primarily due to higher income from investments in equity securities, net, which was $360 million in 2020 compared with $16 million in 2019, largely from the recognition of unrealized gains on securities.

The non-GAAP effective income tax rate was 14.8% for the third quarter of 2020 compared to 15.7% for the third quarter of 2019, reflecting the favorable impact of earnings mix.

Non-GAAP EPS was $1.74 for the third quarter of 2020 compared with $1.51 for the third quarter of 2019.

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

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Third<br> Quarter
$<br> in millions, except EPS amounts 2020 2019
EPS
GAAP<br> EPS $ 1.16 $ 0.74
Difference 0.58 0.77
Non-GAAP<br> EPS that excludes items listed below^2^ $ 1.74 $ 1.51
Net<br> Income
GAAP<br> net income^1^ $ 2,941 $ 1,901
Difference 1,486 1,972
Non-GAAP<br> net income that excludes items listed below^1,2^ $ 4,427 $ 3,873
Decrease<br> (Increase) in Net Income Due to Excluded Items:
Acquisition-<br> and divestiture-related costs^3^ $ 508 $ 975
Restructuring<br> costs 186 296
Charges<br> for acquisitions and collaborations^4^ 1,082 982
Other (1 )
Net<br> decrease (increase) in income before taxes 1,775 2,253
Income<br> tax (benefit) expense^5^ (289 ) (281 )
Decrease<br> (increase) in net income $ 1,486 $ 1,972

FinancialOutlook

The updated full-year guidance that Merck is providing below includes its current assumption of the impact from the COVID-19 pandemic, which is expected to continue to be offset by favorability from underlying business strength. The company continues to assume that the majority of the negative impact occurred during the second quarter. However, it now expects some residual negative impacts in the fourth quarter, largely in Europe and certain emerging markets. In addition, the phasing of the recovery of GARDASIL 9 demand is slower than originally anticipated, in particular in the U.S.

For the full-year 2020, Merck now expects an unfavorable impact to revenue of approximately $2.35 billion (excluding the impact of foreign exchange) due to the COVID-19 pandemic, comprised of approximately $2.3 billion for pharmaceuticals and approximately $50 million for Animal Health, including the impacts in the first three quarters of the year.

For the full-year 2020, Merck now expects a net favorable impact to operating expenses of approximately $625 million, reflecting continued lower spending due to the COVID-19 pandemic, partially offset by spending on its COVID-19-related antiviral and vaccine research programs.

^4^ 2020<br>includes $832 million related to the Seagen collaborations; 2019 represents a charge for the acquisition of Peloton.
^5^ Includes<br>the estimated tax impact on the reconciling items, as well as a tax cost of $67 million, representing an adjustment to the tax<br>benefits recorded in conjunction with the 2015 acquisition of Cubist Pharmaceuticals, Inc.
Page 11

Merck narrowed and raised its full-year 2020 revenue range to be between $47.6 billion and $48.6 billion, including a negative impact from foreign exchange of approximately 1.5% at mid-October exchange rates. The company’s guidance assumes $120 million of revenue for the replenishment of doses of GARDASIL 9 that were borrowed from the U.S. Centers for Disease Control and Prevention (CDC) Pediatric Vaccine Stockpile in the fourth quarter of 2019.

Merck narrowed and lowered its full-year 2020 GAAP EPS range to be between $4.55 and $4.65. Merck narrowed and raised its full-year 2020 non-GAAP EPS range to be between $5.91 and $6.01, including a negative impact from foreign exchange of approximately 2.5% at mid-October exchange rates. The non-GAAP range excludes acquisition- and divestiture-related costs, costs related to restructuring programs and certain other items.

The following table summarizes the company’s full-year 2020 financial guidance.

GAAP Non-GAAP^2^
Revenue $47.6 to $48.6 billion $47.6 to $48.6 billion*
Operating expenses Higher than 2019 by a low-single-digit rate Lower than 2019 by a low-single-digit rate
Effective tax rate Approximately 15% Approximately 15.5%
EPS** $4.55 to $4.65 $5.91 to $6.01

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

**EPS guidance for 2020 assumes a share count (assuming dilution) of approximately 2.54 billion shares.

A reconciliation of anticipated 2020 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 2020
GAAP EPS 4.55 to 4.65
Difference 1.36
Non-GAAP EPS that excludes items listed below^2^ 5.91 to 6.01
Acquisition- and divestiture-related costs 2,300
Restructuring costs 800
Charges for collaborations 1,082
Net decrease (increase) in income before taxes 4,182
Income tax (benefit) expense^5^ (715
Decrease (increase) in net income 3,467

All values are in US Dollars.


EarningsConference 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 https://www.merck.com/investor-relations/events-and-presentations/. Institutional investors and analysts can participate in the call (833) 353-0277 or toll free (469) 886-1947 and using ID code number 4664137. Members of the media are invited to monitor the call by dialing (833) 353-0277 or toll free (469) 886-1947 and using ID code number 4664137. Journalists who wish to ask questions are requested to contact a member of Merck’s Media Relations team at the conclusion of the call.

Page 12

AboutMerck

For more than 125 years, Merck, 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 in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.


Forward-LookingStatement 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 the global outbreak of novel coronavirus disease (COVID-19); 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 2019 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 13

MERCK & CO., INC.

CONSOLIDATEDSTATEMENT OF INCOME - GAAP

(AMOUNTSIN MILLIONS, EXCEPT PER SHARE FIGURES)

(UNAUDITED)

Table1

**** GAAP **** **** GAAP **** ****
**** 3Q20 **** 3Q19 **** %Change **** SepYTD 2020 **** SepYTD 2019 **** %Change ****
Sales $ 12,551 $ 12,397 1 % $ 35,479 $ 34,972 1 %
Costs,<br>Expenses and Other
Cost<br>of sales ^(1)^ 3,481 3,990 -13 % 9,952 10,443 -5 %
Selling,<br>general and administrative ^(1)^ 2,450 2,589 -5 % 7,383 7,726 -4 %
Research<br>and development ^(1)^ 3,390 3,204 6 % 7,721 7,324 5 %
Restructuring<br>costs ^(2)^ 114 232 -51 % 269 444 -39 %
Other<br>(income) expense, net ^(1)^ (312 ) 35 * (630 ) 362 *
Income<br>Before Taxes 3,428 2,347 46 % 10,784 8,673 24 %
Taxes<br>on Income ^(1)^ 483 440 1,611 1,259
Net<br>Income 2,945 1,907 54 % 9,173 7,414 24 %
Less:<br>Net Income (Loss) Attributable to Noncontrolling Interests ^(1)^ 4 6 12 (73 )
Net<br>Income Attributable to Merck & Co., Inc. $ 2,941 $ 1,901 55 % $ 9,161 $ 7,487 22 %
Earnings<br>per Common Share Assuming Dilution $ 1.16 $ 0.74 57 % $ 3.61 $ 2.89 25 %
Average<br>Shares Outstanding Assuming Dilution 2,538 2,572 2,541 2,587
Tax<br>Rate ^(3)^ 14.1 % 18.7 % 14.9 % 14.5 %
*<br> 100% or greater
---
^(1)^Amounts include the impact of acquisition and divestiture-related costs, restructuring costs and certain other items.<br> See accompanying tables for details.
^(2)^Represents separation and other related costs associated with restructuring activities under the company's formal restructuring<br> programs.
^(3)^The effective income tax rates for the third quarter and the first nine months of 2019 include the unfavorable impact<br> of a charge for the acquisition of Peloton Therapeutics, Inc. for which no tax benefit was recognized and the favorable impact<br> of product mix.  The effective income tax rate for the first nine months of 2019 reflects a net tax benefit of $360<br> million related to the settlement of certain federal income tax matters.

MERCK & CO., INC.

GAAPTO NON-GAAP RECONCILIATION

THIRDQUARTER 2020

(AMOUNTSIN MILLIONS, EXCEPT PER SHARE FIGURES)

(UNAUDITED)

Table2a

GAAP Acquisition and Divestiture-Related Costs ^(1)^ Restructuring Costs ^(2)^ Certain Other Items ^(4)^ Adjustment<br><br> Subtotal Non-GAAP
Cost<br> of sales $ 3,481 285 38 323 $ 3,158
Selling,<br> general and administrative 2,450 207 15 222 2,228
Research<br> and development 3,390 16 19 1,082 1,117 2,273
Restructuring<br> costs 114 114 114 -
Other<br> (income) expense, net (312 ) (1 ) (1 ) (311 )
Income<br> Before Taxes 3,428 (508 ) (186 ) (1,081 ) (1,775 ) 5,203
Income<br> Tax Provision (Benefit) 483 (17 )^(3)^ (25 )^(3)^ (247 )^(3)^ (289 ) 772
Net<br> Income 2,945 (491 ) (161 ) (834 ) (1,486 ) 4,431
Net<br> Income Attributable to Merck & Co., Inc. 2,941 (491 ) (161 ) (834 ) (1,486 ) 4,427
Earnings<br> per Common Share Assuming Dilution $ 1.16 (0.19 ) (0.06 ) (0.33 ) (0.58 ) $ 1.74
Tax<br> Rate 14.1 % 14.8 %
Only<br> the line items that are affected by non-GAAP adjustments are shown.
---
Merck<br> is providing certain non-GAAP information that excludes certain items because of the nature of these items and the impact<br> they have on the analysis of underlying business performance and trends. Management believes that providing this information<br> enhances investors’ understanding of the company’s results as it permits investors to understand how management<br> assesses performance. Management uses these measures internally for planning and forecasting purposes and to measure the performance<br> of the company along with other metrics. In addition, senior management’s annual compensation is derived in part using<br> non-GAAP pretax income. This information should be considered in addition to, but not as a substitute for or superior to,<br> information prepared in accordance with GAAP.
^(1)^Amount included in cost of sales primarily reflects expenses for the amortization of intangible assets recognized as<br> a result of business acquisitions.  Amount included in selling, general and administrative expenses reflects $182<br> million related to the company's planned spin-off of Organon & Co., and other acquisition and divestiture-related costs.
^(2)^Amounts primarily include employee separation costs and accelerated depreciation associated with facilities to be closed<br> or divested related to activities under the company's formal restructuring programs.
^(3)^Represents the estimated tax impact on the reconciling items based on applying the statutory rate of the originating<br> territory of the non-GAAP adjustments.  Acquisition and divestiture-related costs also includes a tax cost of $67<br> million, representing an adjustment to the tax benefits recorded in conjunction with the 2015 Cubist Pharmaceuticals, Inc.<br> acquisition.
^(4)^Amount included in research and development reflects expenses for upfront payments related to license and collaboration<br> agreements.

MERCK & CO., INC.

GAAPTO NON-GAAP RECONCILIATION

NINEMONTHS ENDED SEPTEMBER 30, 2020

(AMOUNTSIN MILLIONS, EXCEPT PER SHARE FIGURES)

(UNAUDITED)

Table2b

GAAP Acquisition and Divestiture-Related Costs ^(1)^ Restructuring Costs ^(2)^ Certain Other Items ^(4)^ Adjustment<br><br> Subtotal Non-GAAP
Cost<br> of sales $ 9,952 863 131 994 $ 8,958
Selling,<br> general and administrative 7,383 648 37 685 6,698
Research<br> and development 7,721 (12 ) 67 1,082 1,137 6,584
Restructuring<br> costs 269 269 269 -
Other<br> (income) expense, net (630 ) 52 (17 ) 35 (665 )
Income<br> Before Taxes 10,784 (1,551 ) (504 ) (1,065 ) (3,120 ) 13,904
Income<br> Tax Provision (Benefit) 1,611 (248 )^(3)^ (59 )^(3)^ (242 )^(3)^ (549 ) 2,160
Net<br> Income 9,173 (1,303 ) (445 ) (823 ) (2,571 ) 11,744
Net<br> Income Attributable to Merck & Co., Inc. 9,161 (1,303 ) (445 ) (823 ) (2,571 ) 11,732
Earnings<br> per Common Share Assuming Dilution $ 3.61 (0.51 ) (0.18 ) (0.32 ) (1.01 ) $ 4.62
Tax<br> Rate 14.9 % 15.5 %
Only<br> the line items that are affected by non-GAAP adjustments are shown.
---
Merck<br> is providing certain non-GAAP information that excludes certain items because of the nature of these items and the impact<br> they have on the analysis of underlying business performance and trends. Management believes that providing this information<br> enhances investors’ understanding of the company’s results as it permits investors to understand how management<br> assesses performance. Management uses these measures internally for planning and forecasting purposes and to measure the performance<br> of the company along with other metrics. In addition, senior management’s annual compensation is derived in part using<br> non-GAAP pretax income. This information should be considered in addition to, but not as a substitute for or superior to,<br> information prepared in accordance with GAAP.
^(1)^Amount included in cost of sales primarily reflects expenses for the amortization of intangible assets recognized as<br> a result of business acquisitions.  Amount included in selling, general and administrative expenses reflects $466<br> million related to the company's planned spin-off of Organon & Co., approximately $95 million of costs related to the<br> acquisition of ArQule, Inc., and other acquisition and divestiture-related costs.  Amount included in research and<br> development expenses primarily reflects a reduction in expenses related to a decrease in the estimated fair value measurement<br> of liabilities for contingent consideration.  Amount included in other (income) expense, net, primarily reflects<br> an increase in the estimated fair value measurement of liabilities for contingent consideration related to the termination<br> of the Sanofi-Pasteur MSD joint venture, partially offset by royalty income.
^(2)^Amounts primarily include employee separation costs and accelerated depreciation associated with facilities to be closed<br> or divested related to activities under the company's formal restructuring programs.
^(3)^Represents the estimated tax impact on the reconciling items based on applying the statutory rate of the originating<br> territory of the non-GAAP adjustments.  Acquisition and divestiture-related costs also includes a tax cost of $67<br> million, representing an adjustment to the tax benefits recorded in conjunction with the 2015 Cubist Pharmaceuticals, Inc.<br> acquisition.
^(4)^Amount included in research and development reflects expenses for upfront payments related to license and collaboration<br> agreements.

MERCK & CO., INC.

FRANCHISE/ KEY PRODUCT SALES

(AMOUNTSIN MILLIONS)

(UNAUDITED)

Table3

**** 2020 2019 3Q Sep YTD
**** 1Q 2Q 3Q Sep YTD 1Q 2Q 3Q Sep YTD 4Q Full Year Nom % Ex-Exch % Nom % Ex-Exch %
TOTAL<br> SALES ^(1)^ $ 12,057 $ 10,872 $ 12,551 $ 35,479 $ 10,816 $ 11,760 $ 12,397 $ 34,972 $ 11,868 $ 46,840 1 2 1 3
PHARMACEUTICAL 10,655 9,679 11,320 31,654 9,663 10,460 11,095 31,218 10,533 41,751 2 2 1 3
Oncology
Keytruda 3,284 3,388 3,715 10,387 2,269 2,634 3,070 7,973 3,111 11,084 21 21 30 31
Alliance<br> Revenue – Lynparza ^(2)^ 145 178 196 519 79 111 123 313 132 444 59 58 66 67
Alliance<br> Revenue – Lenvima ^(2)^ 128 151 142 421 74 97 109 280 124 404 30 29 50 50
Emend 43 33 39 115 117 121 98 336 53 388 -60 -59 -66 -65
Vaccines<br> ^(3)^
Gardasil<br> / Gardasil 9 1,097 656 1,187 2,941 838 886 1,320 3,044 693 3,737 -10 -10 -3 -2
ProQuad<br> / M-M-R II / Varivax 435 378 576 1,390 496 675 623 1,794 481 2,275 -8 -7 -23 -22
Pneumovax<br> 23 256 117 375 748 185 170 237 592 334 926 58 58 26 27
RotaTeq 222 168 210 601 211 172 180 564 227 791 16 17 7 8
Vaqta 60 28 51 139 47 58 62 167 71 238 -18 -17 -17 -15
Hospital<br> Acute Care
Bridion 299 224 320 843 255 278 284 817 313 1,131 13 13 3 4
Noxafil 94 73 79 247 190 193 177 560 103 662 -55 -55 -56 -55
Prevymis 60 63 77 200 32 38 45 115 50 165 72 69 74 74
Primaxin 51 64 74 189 59 71 77 207 67 273 -4 -4 -9 -7
Invanz 64 43 51 159 72 78 57 206 57 263 -10 -6 -23 -19
Cancidas 55 43 50 148 61 67 62 191 58 249 -20 -19 -22 -20
Cubicin 46 32 39 116 88 67 52 207 50 257 -26 -25 -44 -43
Zerbaxa 37 32 43 112 26 27 35 88 32 121 22 24 27 29
Immunology
Simponi 215 191 209 615 208 214 203 625 205 830 3 -2 -1
Remicade 88 73 82 242 123 98 101 322 89 411 -19 -20 -25 -24
Neuroscience
Belsomra 79 84 81 244 67 76 80 223 83 306 1 9 8
Virology
Isentress<br> / Isentress HD 245 196 205 646 255 247 250 752 223 975 -18 -18 -14 -12
Zepatier 55 39 28 122 114 108 83 304 66 370 -67 -67 -60 -59
Cardiovascular
Zetia 145 137 103 384 140 156 147 443 146 590 -30 -30 -13 -13
Vytorin 53 39 47 139 97 76 57 231 54 285 -17 -16 -40 -38
Atozet 122 115 111 348 94 92 97 283 108 391 14 12 23 25
Alliance<br> Revenue - Adempas ^(4)^ 53 79 83 216 42 51 50 144 60 204 67 67 50 50
Adempas<br> ^(5)^ 56 57 55 167 48 53 57 158 57 215 -5 -7 6 6
Diabetes<br> ^(6)^
Januvia 774 854 821 2,449 824 908 807 2,539 943 3,482 2 2 -4 -3
Janumet 503 490 506 1,499 530 533 503 1,567 475 2,041 2 -4 -2
Women's<br> Health
Implanon<br> / Nexplanon 195 132 189 515 199 183 199 581 206 787 -5 -4 -11 -10
NuvaRing 63 63 58 184 219 240 241 700 179 879 -76 -76 -74 -73
Diversified<br> Brands
Singulair 155 100 82 338 191 160 152 503 195 698 -46 -46 -33 -32
Cozaar<br> / Hyzaar 102 98 91 292 103 109 116 329 113 442 -21 -20 -11 -9
Arcoxia 70 65 68 204 75 75 72 221 67 288 -5 -2 -8 -5
Nasonex 71 49 41 161 96 72 58 226 67 293 -30 -29 -29 -27
Follistim<br> AQ 41 44 50 136 57 63 62 182 58 241 -18 -18 -26 -25
Other<br> Pharmaceutical ^(7)^ 1,194 1,103 1,186 3,478 1,082 1,203 1,149 3,431 1,183 4,615 3 4 1 3
ANIMAL<br> HEALTH 1,214 1,101 1,220 3,535 1,025 1,124 1,122 3,271 1,122 4,393 9 12 8 12
Livestock 739 648 758 2,145 611 671 726 2,007 777 2,784 5 8 7 11
Companion<br> Animals 475 453 462 1,390 414 453 396 1,264 345 1,609 17 18 10 12
Other<br> Revenues ^(8)^ 188 92 11 290 128 176 180 483 213 696 -94 -33 -40 -12
Sum<br> of quarterly amounts may not equal year-to-date amounts due to rounding.
---
^(1)^Only select products are shown.
^(2)^Alliance Revenue represents Merck’s share of profits, which are product sales net of cost of sales and commercialization<br> costs.
^(3)^Total Vaccines sales were $2,155 million, $1,418 million and $2,521 million in the first, second and third quarters<br> of 2020 and $1,887 million, $2,037 million, $2,517 million and $1,928 million in the first, second, third and fourth quarters<br> of 2019, respectively.
^(4)^Alliance Revenue represents Merck's share of profits from sales in Bayer's marketing territories, which are product<br> sales net of cost of sales and commercialization costs.
^(5)^Net product sales in Merck's marketing territories.
^(6)^Total Diabetes sales were $1,353 million, $1,418 million and $1,405 million in the first, second and third quarters<br> of 2020 and $1,402 million, $1,480 million, $1,360 million and $1,472 million in the first, second, third and fourth quarters<br> of 2019, respectively.
^(7)^Includes Pharmaceutical products not individually shown above.
^(8)^Other Revenues are comprised primarily of Healthcare Services segment revenues, third-party manufacturing sales and<br> miscellaneous corporate revenues, including revenue hedging activities.

Exhibit 99.2

MERCK & CO., INC.

CONSOLIDATEDSTATEMENT OF INCOME - GAAP

(AMOUNTSIN MILLIONS, EXCEPT PER SHARE FIGURES)

(UNAUDITED)

Table1a

2020 2019 %<br> Change
1Q 2Q 3Q Sep YTD 1Q 2Q 3Q Sep YTD 4Q Full Year 3Q Sep YTD
Sales $ 12,057 $ 10,872 $ 12,551 $ 35,479 $ 10,816 $ 11,760 $ 12,397 $ 34,972 $ 11,868 $ 46,840 1 % 1 %
Costs, Expenses and Other
Cost of sales 3,312 3,159 3,481 9,952 3,052 3,401 3,990 10,443 3,669 14,112 -13 % -5 %
Selling, general and administrative 2,555 2,378 2,450 7,383 2,425 2,712 2,589 7,726 2,888 10,615 -5 % -4 %
Research and development 2,209 2,123 3,390 7,721 1,931 2,189 3,204 7,324 2,548 9,872 6 % 5 %
Restructuring costs 72 83 114 269 153 59 232 444 194 638 -51 % -39 %
Other (income) expense, net 71 (390 ) (312 ) (630 ) 188 140 35 362 (223 ) 139 * *
Income Before Taxes 3,838 3,519 3,428 10,784 3,067 3,259 2,347 8,673 2,792 11,464 46 % 24 %
Taxes on Income 619 509 483 1,611 205 615 440 1,259 428 1,687
Net Income 3,219 3,010 2,945 9,173 2,862 2,644 1,907 7,414 2,364 9,777 54 % 24 %
Less: Net Income (Loss) Attributable to Noncontrolling Interests - 8 4 12 (53 ) (26 ) 6 (73 ) 7 (66 )
Net Income Attributable to Merck & Co., Inc. $ 3,219 $ 3,002 $ 2,941 $ 9,161 $ 2,915 $ 2,670 $ 1,901 $ 7,487 $ 2,357 $ 9,843 55 % 22 %
Earnings per Common Share Assuming Dilution $ 1.26 $ 1.18 $ 1.16 $ 3.61 $ 1.12 $ 1.03 $ 0.74 $ 2.89 $ 0.92 $ 3.81 57 % 25 %
Average Shares Outstanding Assuming Dilution 2,547 2,536 2,538 2,541 2,603 2,588 2,572 2,587 2,559 2,580
Tax Rate 16.1 % 14.5 % 14.1 % 14.9 % 6.7 % 18.9 % 18.7 % 14.5 % 15.3 % 14.7 %

* 100% or greater

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

MERCK & CO., INC.

GAAP TO NON-GAAP RECONCILIATION

THIRD QUARTER 2019

(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)

(UNAUDITED)

Table 2c

GAAP Acquisition and Divestiture-Related Costs ^(1)^ Restructuring Costs ^(2)^ CertainOther Items ^(4)^ Adjustment<br><br> Subtotal Non-GAAP
Cost of sales $ 3,990 941 62 1,003 $ 2,987
Selling, general and administrative 2,589 22 1 23 2,566
Research and development 3,204 6 1 982 989 2,215
Restructuring costs 232 232 232 -
Other (income) expense, net 35 6 6 29
Income Before Taxes 2,347 (975 ) (296 ) (982 ) (2,253 ) 4,600
Income Tax Provision (Benefit) 440 (231 )^(3)^ (50 )^(3)^ - (281 ) 721
Net Income 1,907 (744 ) (246 ) (982 ) (1,972 ) 3,879
Net Income Attributable to Merck & Co., Inc. 1,901 (744 ) (246 ) (982 ) (1,972 ) 3,873
Earnings per Common Share Assuming Dilution $ 0.74 (0.29 ) (0.10 ) (0.38 ) (0.77 ) $ 1.51
Tax Rate 18.7 % 15.7 %

Only the line items that are affected by non-GAAP adjustments are shown.

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

^(1)^Amount included in cost of sales primarily reflects $320 million of expenses for the amortization of intangible assets recognized as a result of business acquisitions, as well as $612 million of intangible asset impairment charges related to SIVEXTRO.  Amount included in selling, general and administrative expenses primarily reflects integration, transaction and certain other costs related to business acquisitions and divestitures.

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

^(3)^ Represents the estimated tax impact on the reconciling items based on applying the statutory rate of the originating territory of the non-GAAP adjustments.

^(4)^ Amount included in research and development represents the charge related to the acquisition of Peloton Therapeutics, Inc.

MERCK & CO., INC.

GAAP TO NON-GAAP RECONCILIATION

NINE MONTHS ENDED SEPTEMBER 30, 2019

(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)

(UNAUDITED)

Table 2d

GAAP Acquisition and Divestiture-Related Costs ^(1)^ Restructuring Costs ^(2)^ Certain Other Items ^(4)^ Adjustment<br> Subtotal Non-GAAP
Cost of sales $ 10,443 1,801 161 1,962 $ 8,481
Selling, general and administrative 7,726 82 33 115 7,611
Research and development 7,324 (21 ) 4 982 965 6,359
Restructuring costs 444 444 444 -
Other (income) expense, net 362 321 48 369 (7 )
Income Before Taxes 8,673 (2,183 ) (642 ) (1,030 ) (3,855 ) 12,528
Income Tax Provision (Benefit) 1,259 (438 )^(3)^ (106 )^(3)^ (304 )^(5)^ (848 ) 2,107
Net Income 7,414 (1,745 ) (536 ) (726 ) (3,007 ) 10,421
Less: Net (Loss) Income Attributable to Noncontrolling Interests (73 ) (89 ) (89 ) 16
Net Income Attributable to Merck & Co., Inc. 7,487 (1,656 ) (536 ) (726 ) (2,918 ) 10,405
Earnings per Common Share Assuming Dilution $ 2.89 (0.64 ) (0.21 ) (0.28 ) (1.13 ) $ 4.02
Tax Rate 14.5 % 16.8 %

Only the line items that are affected by non-GAAP adjustments are shown.

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

^(1)^Amount included in cost of sales primarily reflects $1.1 billion of expenses for the amortization of intangible assets recognized as a result of business acquisitions, as well as $693 million of intangible asset impairment charges, including $612 million related to SIVEXTRO.  Amount included in selling, general and administrative expenses primarily reflects integration, transaction and certain other costs related to business acquisitions and divestitures, including costs related to the acquisition of Antelliq Corporation.  Amount included in research and development expenses primarily reflects a reduction in expenses related to a decrease in the estimated fair value measurement of liabilities for contingent consideration.  Amount included in other (income) expense, net primarily reflects goodwill and intangible asset impairment charges related to certain businesses in the Healthcare Services segment and expenses related to an increase in the estimated fair value measurement of liabilities for contingent consideration, partially offset by royalty income related to the termination of the Sanofi-Pasteur MSD joint venture.

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

^(3)^ Represents the estimated tax impact on the reconciling items based on applying the statutory rate of the originating territory of the non-GAAP adjustments.

^(4)^ Amount included in research and development represents the charge related to the acquisition of Peloton Therapeutics, Inc.

^(5)^ Primarily reflects a $360 million net tax benefit related to the settlement of certain federal income tax matters and a $67 million tax charge related to the finalization of treasury regulations associated with the 2017 enactment of U.S. tax legislation.

MERCK & CO., INC.

FRANCHISE / KEY PRODUCT SALES

THIRD QUARTER 2020

(AMOUNTS IN MILLIONS)

(UNAUDITED)

Table 3a

Global U.S. International
3Q 2020 3Q 2019 % Change 3Q 2020 3Q 2019 % Change 3Q 2020 3Q 2019 % Change
TOTAL<br> SALES ^(1)^ $ 12,551 $ 12,397 1 $ 5,625 $ 5,573 1 $ 6,926 $ 6,824 1
PHARMACEUTICAL 11,320 11,095 2 5,218 5,180 1 6,102 5,914 3
Oncology
Keytruda 3,715 3,070 21 2,157 1,743 24 1,559 1,327 17
Alliance<br> Revenue - Lynparza ^(2)^ 196 123 59 107 71 52 89 53 70
Alliance<br> Revenue - Lenvima ^(2)^ 142 109 30 82 65 26 60 44 36
Emend 39 98 -60 8 42 -82 31 56 -44
Vaccines<br> ^(3)^
Gardasil<br> / Gardasil 9 1,187 1,320 -10 579 761 -24 608 558 9
ProQuad<br> / M-M-R II / Varivax 576 623 -8 437 482 -9 139 141 -2
Pneumovax<br> 23 375 237 58 276 179 54 99 58 72
RotaTeq 210 180 16 114 102 11 96 78 23
Vaqta 51 62 -18 32 36 -11 19 26 -26
Hospital<br> Acute Care
Bridion 320 284 13 162 133 22 157 151 4
Noxafil 79 177 -55 13 77 -83 66 100 -34
Prevymis 77 45 72 32 22 42 46 23 101
Primaxin 74 77 -4 1 2 -34 73 75 -3
Invanz 51 57 -10 1 (1 ) * 50 58 -14
Cancidas 50 62 -20 1 0 80 49 62 -21
Zerbaxa 43 35 22 20 20 4 23 15 47
Cubicin 39 52 -26 11 14 -22 28 38 -28
Immunology
Simponi 209 203 3 209 203 3
Remicade 82 101 -19 82 101 -19
Neuroscience
Belsomra 81 80 1 18 23 -24 63 57 11
Virology
Isentress<br> / Isentress HD 205 250 -18 92 102 -10 113 149 -24
Zepatier 28 83 -67 6 24 -76 22 59 -63
Cardiovascular
Zetia 103 147 -30 (1 ) 5 -115 103 142 -27
Vytorin 47 57 -17 3 5 -34 44 52 -16
Atozet 111 97 14 111 97 14
Alliance<br> Revenue - Adempas ^(4)^ 83 50 67 78 48 64 5 2 117
Adempas<br> ^(5)^ 55 57 -5 55 57 -5
Diabetes<br> ^(6)^
Januvia 821 807 2 342 367 -7 479 440 9
Janumet 506 503 105 129 -18 400 375 7
Women's<br> Health
Implanon<br> / Nexplanon 189 199 -5 137 136 1 52 62 -17
NuvaRing 58 241 -76 24 202 -88 34 39 -13
Diversified<br> Brands
Cozaar<br> / Hyzaar 91 116 -21 5 6 -7 86 110 -22
Singulair 82 152 -46 4 11 -61 78 140 -44
Arcoxia 68 72 -5 68 72 -5
Follistim<br> AQ 50 62 -18 20 27 -28 31 35 -11
Nasonex 41 58 -30 4 -110 41 55 -24
Other<br> Pharmaceutical ^(7)^ 1,186 1,149 3 352 343 3 834 804 4
ANIMAL<br> HEALTH 1,220 1,122 9 398 337 18 822 785 5
Livestock 758 726 5 164 144 14 594 582 2
Companion<br> Animals 462 396 17 234 193 22 228 203 12
Other<br> Revenues ^(8)^ 11 180 -94 9 56 -85 2 125 -99

* 200% or greater

Sum of U.S. plus international may not equal global due to rounding.

^(1)^Only select products are shown.

^(2)^Alliance Revenue represents Merck’s share of profits, which are product sales net of cost of sales and commercialization costs.

^(3)^Total Vaccines sales were $2,521 million and $2,517 million on a global basis in the third quarter of 2020 and 2019, respectively.

^(4)^Alliance Revenue represents Merck's share of profits from sales in Bayer's marketing territories, which are product sales net of cost of sales and commercialization costs.

^(5)^Net product sales in Merck's marketing territories.

^(6)^Total Diabetes sales were $1,405 million and $1,360 million on a global basis in the third quarter of 2020 and 2019, respectively.

^(7)^Includes Pharmaceutical products not individually shown above.

^(8)^Other Revenues are comprised primarily of Healthcare Services segment revenue, third-party manufacturing sales and miscellaneous corporate revenues, including revenue hedging activities.

MERCK & CO., INC.

FRANCHISE / KEY PRODUCT SALES

SEPTEMBER YEAR-TO-DATE 2020

(AMOUNTS IN MILLIONS)

(UNAUDITED)

Table 3b

Global U.S. International
Sep<br> YTD 2020 Sep<br> YTD 2019 %<br> Change Sep<br> YTD 2020 Sep<br> YTD 2019 %<br> Change Sep<br> YTD 2020 Sep<br> YTD 2019 %<br> Change
TOTAL<br> SALES ^(1)^ $ 35,479 $ 34,972 1 $ 15,396 $ 15,320 $ 20,084 $ 19,652 2
PHARMACEUTICAL 31,654 31,218 1 14,202 14,202 17,452 17,016 3
Oncology
Keytruda 10,387 7,973 30 6,106 4,525 35 4,281 3,448 24
Alliance<br> Revenue - Lynparza ^(2)^ 519 313 66 297 186 59 223 126 76
Alliance<br> Revenue - Lenvima ^(2)^ 421 280 50 270 169 60 152 112 36
Emend 115 336 -66 18 173 -89 96 163 -41
Vaccines<br> ^(3)^
Gardasil<br> / Gardasil 9 2,941 3,044 -3 1,209 1,579 -23 1,732 1,464 18
ProQuad<br> / M-M-R II / Varivax 1,390 1,794 -23 1,033 1,325 -22 356 469 -24
Pneumovax<br> 23 748 592 26 478 428 12 270 164 64
RotaTeq 601 564 7 355 360 -2 246 203 21
Vaqta 139 167 -17 79 103 -23 60 65 -7
Hospital<br> Acute Care
Bridion 843 817 3 412 381 8 431 437 -1
Noxafil 247 560 -56 27 268 -90 220 291 -25
Prevymis 200 115 74 87 60 45 113 55 106
Primaxin 189 207 -9 2 2 187 204 -9
Invanz 159 206 -23 7 30 -77 152 176 -14
Cancidas 148 191 -22 2 5 -63 147 187 -21
Cubicin 116 207 -44 36 78 -54 80 129 -37
Zerbaxa 112 88 27 57 45 27 54 43 26
Immunology
Simponi 615 625 -2 615 625 -2
Remicade 242 322 -25 242 322 -25
Neuroscience
Belsomra 244 223 9 67 68 -2 177 155 14
Virology
Isentress<br> / Isentress HD 646 752 -14 243 304 -20 403 449 -10
Zepatier 122 304 -60 38 96 -60 83 208 -60
Cardiovascular
Zetia 384 443 -13 (4 ) 11 -140 389 432 -10
Vytorin 139 231 -40 9 11 -23 130 219 -41
Atozet 348 283 23 348 283 23
Alliance<br> Revenue - Adempas ^(4)^ 216 144 50 200 137 46 16 7 130
Adempas<br> ^(5)^ 167 158 6 167 158 6
Diabetes<br> ^(6)^
Januvia 2,449 2,539 -4 1,110 1,223 -9 1,339 1,317 2
Janumet 1,499 1,567 -4 361 462 -22 1,138 1,105 3
Women's<br> Health
Implanon<br> / Nexplanon 515 581 -11 374 421 -11 142 160 -12
NuvaRing 184 700 -74 85 593 -86 98 107 -8
Diversified<br> Brands
Singulair 338 503 -33 14 24 -44 324 479 -32
Cozaar<br> / Hyzaar 292 329 -11 17 16 6 275 313 -12
Arcoxia 204 221 -8 204 221 -8
Nasonex 161 226 -29 9 2 * 152 224 -32
Follistim<br> AQ 136 182 -26 60 80 -26 76 102 -26
Other<br> Pharmaceutical ^(7)^ 3,478 3,431 1 1,144 1,037 10 2,334 2,394 -3
ANIMAL<br> HEALTH 3,535 3,271 8 1,124 966 16 2,411 2,305 5
Livestock 2,145 2,007 7 448 406 10 1,697 1,601 6
Companion<br> Animals 1,390 1,264 10 676 560 21 714 704 2
Other<br> Revenues ^(8)^ 290 483 -40 70 152 -54 221 331 -33

* 200% or greater

Sum of U.S. plus international may not equal global due to rounding.

^(1)^Only select products are shown.

^(2)^Alliance Revenue represents Merck’s share of profits, which are product sales net of cost of sales and commercialization costs.

^(3)^Total Vaccines sales were $6,094 million and $6,441 million on a global basis for September YTD 2020 and 2019, respectively.

^(4)^Alliance Revenue represents Merck's share of profits from sales in Bayer's marketing territories, which are product sales net of cost of sales and commercialization costs.

^(5)^Net product sales in Merck's marketing territories.

^(6)^Total Diabetes sales were $4,177 million and $4,242 million on a global basis for September YTD 2020 and 2019, respectively.

^(7)^Includes Pharmaceutical products not individually shown above.

^(8)^Other Revenues are comprised primarily of Healthcare Services segment revenues, third-party manufacturing sales and miscellaneous corporate revenues, including revenue hedging activities.

MERCK & CO., INC.

PHARMACEUTICAL GEOGRAPHIC SALES

(AMOUNTS IN MILLIONS)

(UNAUDITED)

Table 3c

2020 2019 %<br> Change
1Q 2Q 3Q Sep<br> YTD 1Q 2Q 3Q Sep<br> YTD 4Q Full<br> Year 3Q
TOTAL<br> PHARMACEUTICAL $ 10,655 $ 9,679 $ 11,320 $ 31,654 $ 9,663 $ 10,460 $ 11,095 $ 31,218 $ 10,533 $ 41,751 2
United States ^(1)^ 4,714 4,270 5,218 14,202 4,215 4,807 5,180 14,202 4,751 18,953 1
%<br> Pharmaceutical Sales 44.2 % 44.1 % 46.1 % 44.9 % 43.6 % 46.0 % 46.7 % 45.5 % 45.1 % 45.4 %
Europe ^(2)^ 2,543 2,196 2,549 7,288 2,335 2,301 2,304 6,941 2,373 9,314 11
%<br> Pharmaceutical Sales 23.9 % 22.7 % 22.5 % 23.0 % 24.2 % 22.0 % 20.8 % 22.2 % 22.5 % 22.3 %
China 846 811 990 2,646 725 745 898 2,368 773 3,141 10
%<br> Pharmaceutical Sales 7.9 % 8.4 % 8.7 % 8.4 % 7.5 % 7.1 % 8.1 % 7.6 % 7.3 % 7.5 %
Japan 789 847 805 2,441 779 900 894 2,573 921 3,494 -10
%<br> Pharmaceutical Sales 7.4 % 8.8 % 7.1 % 7.7 % 8.1 % 8.6 % 8.1 % 8.2 % 8.7 % 8.4 %
Asia Pacific (other<br> than China and Japan) 613 555 601 1,769 642 606 638 1,886 614 2,500 -6
%<br> Pharmaceutical Sales 5.8 % 5.7 % 5.3 % 5.6 % 6.6 % 5.8 % 5.8 % 6.0 % 5.8 % 6.0 %
Eastern Europe/Middle<br> East/Africa 490 416 419 1,325 343 388 423 1,154 423 1,577 -1
%<br> Pharmaceutical Sales 4.6 % 4.3 % 3.7 % 4.2 % 3.6 % 3.7 % 3.8 % 3.7 % 4.0 % 3.8 %
Latin America 419 399 477 1,294 427 523 534 1,484 429 1,914 -11
%<br> Pharmaceutical Sales 3.9 % 4.1 % 4.2 % 4.1 % 4.4 % 5.0 % 4.8 % 4.8 % 4.1 % 4.6 %
Canada 212 160 216 589 177 179 211 568 216 783 2
%<br> Pharmaceutical Sales 2.0 % 1.7 % 1.9 % 1.9 % 1.8 % 1.7 % 1.9 % 1.8 % 2.0 % 1.9 %
Other ^(1)^ 29 25 45 100 20 11 13 42 33 75 246
%<br> Pharmaceutical Sales 0.3 % 0.3 % 0.4 % 0.3 % 0.2 % 0.1 % 0.1 % 0.1 % 0.3 % 0.2 %

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

^(1)^Alliance revenue related to Adempas attributable to the United States has been reclassified from Other.

^(2)^Europe primarily represents all European Union countries and the European Union accession markets.

MERCK & CO., INC.

OTHER (INCOME) EXPENSE, NET - GAAP

(AMOUNTS IN MILLIONS)

(UNAUDITED)

Table 4

OTHER (INCOME) EXPENSE, NET

3Q20 3Q19 Sep YTD 2020 Sep YTD 2019
Interest income $ (9 ) $ (61 ) $ (48 ) $ (225 )
Interest expense 203 231 624 674
Exchange losses 10 38 89 166
Income from investments in equity securities, net ^(1)^ (360 ) (16 ) (964 ) (50 )
Net periodic defined benefit plan (credit) cost other than service cost (88 ) (128 ) (259 ) (409 )
Other, net (68 ) (29 ) (72 ) 206
Total $ (312 ) $ 35 $ (630 ) $ 362

^(1)^Includes net realized and unrealized gains and losses from investments in equity securities either owned directly or through ownership interests in investment funds.  Unrealized gains and losses from investments that are directly owned are determined at the end of the reporting period, while ownership interests in investment funds are accounted for on a one quarter lag.