merck investor presentation june 2015 6-25-2015 final

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Investor Presentation June 2015 Merck & Co., Inc.

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Merck Investor Presentation June 2015 6-25-2015 FINAL

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  • Investor Presentation June 2015

    Merck & Co., Inc.

  • Forward-Looking Statement of Merck & Co., Inc., Kenilworth, NJ, USA

    This presentation of Merck & Co., Inc., Kenilworth, NJ, USA (the Company) 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 the Companys management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

    Risks and uncertainties include, but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare legislation in the United States and internationally; global trends toward healthcare cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the Companys 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 Companys 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 Companys 2014 Annual Report on Form 10-K and the companys other filings with the Securities and Exchange Commission (SEC) available at the SECs Internet site (www.sec.gov).

    2

  • Merck is Positioned for Long-Term Growth through Innovation

    Premier Research-Driven Biopharmaceutical Company

    New Focused Model Suite of Opportunities

    Improving Operating Model

    Accelerating BD Strategy

    Four Key Growth Platforms

    Multiple New Product Launches

    Programs in Areas with Large Unmet Needs

    Advancing Innovative Pipeline

    3

  • Investing Behind Products and Programs with the Greatest Returns Focus on Candidates with Unambiguous Promotable Advantages Resourcing Launch Opportunities Prioritization of Investment Leading to Overall Reduction in OpEx

    New Focused Model is Driving Growth and Productivity

    4

    Corporate

    Commercial

    Operating Expense

    On track for $2.5B of cost savings by end of 2015 vs. 2012 base

    Investing Behind the Best Sources of Growth Rigorous Portfolio Prioritization: Retaining Animal Health Divesting Non-Core Assets, including Consumer Care and Ophthalmics Acquiring Complementary Assets, including Idenix and Cubist

    4 Priority Commercial Areas Top 10 Priority Markets Integrated Oncology Business Unit

  • Total deaths from diabetes are projected to increase by 50% in the next 10 years

    Antibiotic-resistant bacteria infects over 2 million Americans annually, resulting in 23,000 deaths

    HOSPITAL ACUTE CARE

    DIABETES

    Prevention of disease through vaccination is cost effective

    VACCINES

    Every year, 8 million people die from cancer worldwide

    ONCOLOGY

    Focused Areas Provide a Platform for Growth

    5 Sources: CDC, WHO

  • Growth from Core Commercial Areas and Launches

    Diabetes Hospital Acute Care Oncology Vaccines

    KEYTRUDA (Melanoma) KEYTRUDA (NSCLC) BELSOMRA GARDASIL9 ZERBAXA

    Core Focus Areas

    Current and Near-term Launches

    Potential Future Launches

    Sales

    Innovation MK-5172A (HCV)

    Odanacatib (Osteoporosis)

    Omarigliptin (Diabetes)

    Anacetrapib (Atherosclerosis)

    Doravirine (HIV)

    MK-8931 (Alzheimers Disease)

    Biosimilars Immunology Oncology Insulin

    WAVE 1 WAVE 2

    6

  • 7

    $83mm in 1Q 2015 sales

    Vast majority of ipilimumab-refractory melanoma patients being treated with KEYTRUDA

    Strong access in labeled indication

    Broad acceptance of KEYTRUDA in NCCN melanoma treatment guidelines

    Launching New Products in Large Markets

    Now launching in U.S. and Japan

    ~5,500 weekly prescriptions (mid-June)1

    Achieved positive coverage decisions for ~50mm commercial lives, half with no step edit

    Launch ongoing in U.S.

    Beginning to see formulary additions

    Growing issues with Gram-negative pathogens, including certain resistant species, driving positive discussions and positive formulary uptake

    1. Source: IMS.

  • Merck is Advancing its Innovative Pipeline

    2015 2016 2017 2018 2019+ 2014

    KEYTRUDA NSCLC (KN-010)

    Grazoprevir / Elbasvir (Hepatitis C)

    KEYTRUDA Bladder Cancer (KN-045)

    Anacetrapib (Atherosclerosis)

    Actoxumab / Bezlotoxumab (C. Diff. Infection)

    Ertugliflozin* (SGLT-2 Inhibitor)

    Letermovir (HCMV prophylaxis)

    BACE Inhibitor (Alzheimers Disease)

    Surotomycin (C. Diff. Infection)

    Earliest study primary completion date per clinicaltrials.gov Latest study primary completion date per clinicaltrials.gov

    KEYTRUDA Head & Neck Cancer (KN-040)

    Omarigliptin* (once weekly DPP-4)

    8

    Doravirine (HIV)

    * Light green arrow reflects CV outcomes studies for Omarigliptin and Ertugliflozin.

    Dates per clinicaltrials.gov as of 5/19/2015

  • KEYTRUDA: Building a Foundation with Monotherapy

    9

    Over 30 Different Tumor Types Under Investigation

    Melanoma NSCLC

    Mesothelioma SCLC

    Esophageal Ovarian Renal

    Colorectal

    Head and Neck Bladder Gastric TNBC

    Hodgkins Lymphoma

    Wave 1 Wave 2 Wave 3

  • Overall Response Rate in Advanced NSCLC by PD-L1 Proportion Score (KEYNOTE-001)

    45.2 43.9 50.0 16.5 15.6 19.2 10.7 9.1 16.7 0

    102030405060708090

    100

    OR

    R (9

    5% C

    I), %

    PS 50% PS 1-49% PS

  • Lung Cancer: Largest Global Incidence and Worst Mortality

    Source: GLOBOCAN 2012: Estimated cancer incidence, mortality and prevalence worldwide, in 2012.

    0 500,000 1,000,000 1,500,000 2,000,000

    Lung Breast

    Colorectum Prostate Stomach

    LiverHead & Neck

    CervixEsophagus

    Bladder Non-Hodgkin's lymphoma

    Leukemia Pancreas

    KidneyEndometrium

    Thyroid Brain & CNS

    Ovary Melanoma

    Gallbladder Multiple myeloma

    Hodgkin's lymphoma

    IncidenceMortality

    Number of Cancer Cases Per Year

    Incidence of Lung Cancer ~8x Melanoma

    11

  • Improving Efficacy with Selective Combination Therapy

    Standard Therapies

    Targeted Therapies

    Immuno-modulators

    Novel Vaccines

    Combination Strategy More than 40 Combinations Under Investigation

    12

  • REGISTRATION

    Broad Pipeline is Advancing Rapidly

    EARLY CLINICAL DEVELOPMENT

    13

    KEYTRUDA NMEs

    Over 30 Different Tumors Over 40 Different Combinations

    MK-8628 (BET inhibitor): Solid tumors, hematologic malignancies

    MK-4166 (Anti-GITR): Solid tumors

    MK-1966 (anti-IL-10) + SD-101 (Dynavax): Solid and hematological tumors*

    Melanoma 1L (KN006) 2L (KN002) Adjuvant (KN054) T-Vec combination (Amgen)*

    NSCLC 1L (KN024) 1L (KN042) 2/3 L (KN010)

    Head and Neck 1L + chemo/cetuximab (KN048) 2L (KN040) 3L (KN055)

    Bladder 1L (KN052) 2L (KN045)

    Gastric 2L (KN061) 3L (KN059)

    Colorectal 3L MSI-high (KN164)*

    Triple Negative Breast 2L (KN086)

    RRcHL 3L (KN087)

    *Planned

  • Merck Oncology: Broad Universe of Partnerships

    14

  • Potential Launches in Multiple Tumor Types

    OTHERS

    BLADDER

    MELANOMA

    HEAD & NECK

    NON-SMALL- CELL LUNG

    GASTRIC

    CLASSICAL HODGKINS LYMPHOMA

    TRIPLE NEGATIVE BREAST CANCER

    15

    ADVANCED PLEURAL

    MESOTHELIOMA

    Initial market entry in metastatic melanoma Potential second indication in non-small-cell lung cancer Possible application in up to 30 different types of tumors

  • High rates of efficacy* demonstrated against key genotypes High barrier to resistance and activity against common resistance-

    associated variants of HCV Single tablet given once-daily, no significant food effect Breakthrough designation from FDA for selected populations File submitted to FDA (May 28, 2015)

    HCV NS3/4A inhibitor (100 mg once-daily, oral)

    All-oral, once-daily, fixed-dose tablet

    HCV NS5A inhibitor (50 mg, once-daily, oral)

    Grazoprevir/Elbasvir regimen for the treatment of HCV infection

    Grazoprevir (MK-5172)

    Elbasvir (MK-8742)

    *Defined as Sustained Virologic Response 12 weeks post-treatment, or SVR12. 16

  • C-CREST: Phase 2 program evaluates two different 3-drug regimens Designed to target broad range of genotypes Starts with 8 week regimens, and based on the results, will proceed to

    investigate shorter durations

    Looking to the future: The Merck triplet regimens

    HCV NS5B Nucleoside inhibitor

    HCV NS3/4A inhibitor HCV NS5A inhibitor

    Grazoprevir (MK-5172)

    Elbasvir (MK-8742) or

    MK-8402 MK-3682

    17

  • ~$30 billion global atherosclerosis market1

    Phase 3 fully enrolled

    Oral, once-daily, tablet being tested as additive therapy to statins

    Study completion targeted for early 2017

    ~6 million people expected to have Alzheimers Disease in U.S. by 20202

    Two Phase 3 studies enrolling mild-to-moderate or prodromal patients

    BACE inhibitor prevents the formation of A-Beta peptides

    First study completion targeted for early 2017

    Anacetrapib: CETP Inhibitor for CV disease

    BACE Inhibitor for Alzheimers Disease

    Merck has Phase 3 Studies in Large Markets with Unmet Need

    18 1. Source: IMS. 2. Source: 2014 Alzheimers Disease Facts and Figures, Alzheimers Association.

  • Mercks BD Strategy is Adding Value and Increasing Focus

    19

    Idenix (HCV) Cubist (Hospital Care) OncoEthix (Oncology) Multiple Oncology

    collaborations NewLink (Ebola Vaccine) Bayer CV collaboration NGM collaboration1 Moderna collaboration

    Consumer Care Ophthalmology Saphris Diversified Brands (Aspen) Anti-IL-23

    Acquiring

    Divesting

    1. Collaboration focused on Diabetes, Metabolic Dysregulation, and Oncology.

  • Merck Will Invest in the Business While Returning Cash to Shareholders

    22

    5

    17

    -10

    15

    5

    Cumulative Capital Allocation (2012-2014)

    R&D1

    20

    1. Non-GAAP R&D, as reported. 2. Change in Accounts Receivable, Inventories, and Trade Accounts Payable as reported on the Cash Flow Statement. 3. Acquisitions as reported on the Cash Flow Statement. 4. Divestitures as reported on the Cash Flow Statement, net of cash tax.

    Invest excess cash in BD above hurdle rate; Otherwise return cash to shareholders

    Fund the Business and Pay the Dividend

    Capex & Working Capital

    Change2

    Dividend Share Repurchase

    BD3

    Divestitures4

    $ billions

  • Merck is Creating Value and Returning Cash to Shareholders

    0

    5

    10

    15

    2014 2013 2012 2011 2010

    Dividends Paid Share Repurchase

    $ bi

    llion

    s

    21

    Dividends and share repurchases > 90% of Free Cash Flow

    ~$3B share repurchases annually (historically)

    Grow dividend per share annually

  • 2015: Merck Looking Forward to...

    Growth in core areas

    Multiple product launches ongoing

    Near-term regulatory action for key programs

    Targeting business development to drive long-term value

    22

    Merck & Co., Inc.Forward-Looking Statement of Merck & Co., Inc., Kenilworth, NJ, USAMerck is Positioned for Long-Term Growth through InnovationNew Focused Model is Driving Growth and ProductivityFocused Areas Provide a Platform for GrowthGrowth from Core Commercial Areas and LaunchesLaunching New Products in Large MarketsMerck is Advancing its Innovative PipelineKEYTRUDA: Building a Foundation with MonotherapyOverall Response Rate in Advanced NSCLCby PD-L1 Proportion Score (KEYNOTE-001)Lung Cancer: Largest Global Incidence and Worst MortalityImproving Efficacy with Selective Combination TherapyBroad Pipeline is Advancing RapidlyMerck Oncology: Broad Universe of PartnershipsPotential Launches in Multiple Tumor TypesGrazoprevir/Elbasvir regimen for the treatment of HCV infectionLooking to the future: The Merck triplet regimensMerck has Phase 3 Studies in Large Markets with Unmet NeedMercks BD Strategy is Adding Value and Increasing FocusMerck Will Invest in the Business While Returning Cash to ShareholdersMerck is Creating Value and Returning Cash to Shareholders2015: Merck Looking Forward to...