2017 annual meeting of...
TRANSCRIPT
Forward-Looking Statement 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 U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include, but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and 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 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 2016 Annual Report on Form 10-K and the Company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
Merck Has A Rich Heritage of Bringing Groundbreaking Products To Market
With Potential Future Innovations
ALZHEIMER’S AMR ATHEROSCLEROSIS DIABETES HIV VACCINES
And Many More…
• INTRON A
• RECOMBIVAX
• ZOCOR
• VASOTEC . . .
1980’s
• VARIVAX
• FOSAMAX
• CRIXIVAN
• SINGULAIR . . .
1990’s
• JANUVIA
• GARDASIL
• ISENTRESS
• ZOSTAVAX . . .
2000’s
• KEYTRUDA
• ZEPATIER
• BELSOMRA
• VICTRELIS . . .
2010’s
• MMR
• PRIMAXIN
• PNEUMOVAX
• MEFOXIN . . .
< 1970’s
WE THINK THEY’RE THE
Most Important Kind
95% OF PEOPLE SURVEYED
DON’T THINK OF NEW MEDICINES
AS THE MOST
Impactful Inventions
What Invention Can’t You Wait For?
NINI, Age 3 in remission since 2016
Performance Driven by Broad and Balanced Portfolio
Oncology | Diabetes | Vaccines Animal Health | Hospital Acute Care
2016 GROWTH
2017: Strong First Quarter Performance
Oncology Vaccines
Animal Health
1Q17 GROWTH
Launches Results
$0.56 GAAP EPS
$0.88 Non-GAAP EPS
NSCLC: Approved in 1L as monotherapy (PD-L1+ high expressers) and in combination (pemetrexed/carboplatin) in all comers non-squamous; approved in all PD-L1+ in 2L
Melanoma: Approved in 1L+
Head and Neck: Approved in U.S.
Classical Hodgkin Lymphoma: Approved in U.S. and E.U.
Bladder: Approved in 1L and 2L settings
FDA Breakthrough Therapy Designation in multiple tumor types
>10 internally-owned I/O mechanisms with several already in the clinic
Broadest clinical program of any Anti-PD-1/PD-L1 > 500 clinical studies across 30 tumor types > 300 combinations > 40 potential registration-enabling studies
Launched in >50 Markets
KEYTRUDA: Progress in Developing More Effective Cancer Treatments
May 23, 2017
Roger M. Perlmutter, M.D., Ph.D.
PD-1 and PD-L1/L2 Pathway PD-1 is an immune checkpoint receptor Binding of PD-1 by its ligands PD-L1 or PD-L2 leads to downregulation of T-cell function
This mechanism is usurped by many tumors PD-1 blockade through mAb therapy can reveal effective anti-tumor immunity Topalian et al. N Engl J Med. 2012.
Garon et al. N Engl J Med. 2015. Robert et al. Lancet. 2014.
Treatment of Advanced, Metastatic Melanoma with KEYTRUDA Baseline: 13 April 2012 27 July 2012
• 72 year-old male with melanoma whose disease progressed following chemotherapy, high-dose IL-2, and ipilimumab
• Patient was placed on oxygen support due to progressive lung disease burden and pleural effusion
• After 3 months of MK-3475, the patient no longer required oxygen support
Courtesy of A. Ribas M.D.
-100
0
100
-100
0
100
KEYTRUDA Monotherapy Has Shown Activity in >20 Tumors
-100
0
100
-100
0
100Melanoma1
-100
0
100 NSCLC2
-100
0
100Gastric6
-100
0
100
-100
0
100H&N3 TNBC5
-100
0
100cHL7
-100
0
100NHL PMBCL8
Urothelial4
Chan
ge F
rom
Bas
eline
in Tu
mor
Size
, %
-100
0
100Mesothelioma9
-100
0
100Anal14
-100
0
100
-100
0
100SCLC11
-100
0
100NPC13
-100
0
100Biliary Tract15
-100
0
100Colorectal16
Esophageal12
-100
0
100Ovarian10
-100
0
100ER+/HER2– BC17
1. Daud A et al. ASCO 2015; 2. Garon EB et al. ESMO 2014; 3. Seiwert T et al. ASCO 2015; 4. Plimack E et al. ASCO 2015; 5. Nanda R et al. SABCS 2014; 6. Bang YJ et al. ASCO 2015 ; 7. Moskowitz C et al. ASH 2014; 8. Zinzani PL et al. ASH 2015; 9. Alley EA et al. AACR 2015; 10. Varga A et al. ASCO 2015; 11. Ott PA et al. 2015 ASCO; 12. Doi T et al. ASCO 2015; 13. Hsu C et al. ECC 2015; 14. Ott PA et al. ECC 2015; 15. Bang Y-J et al. ECC 2015; 16. O’Neil B et al. ECC 2015; 17. Rugo HS et al. SABCS 2015; 18. Frenel JS et al. ASCO 2016; 19. Mehnert JM et al. ASCO 2016; 20. Cohen R et al. ASCO 2016.
Cervical18 Thyroid19 Salivary20
-100
0
100
KEYTRUDA Development Efforts are Increasing Rapidly with Many Trials Just Beginning. . .Including Many Combination Studies
Bladder MELANOMA
H& N
NSCLC
GASTRIC
TNBC cHL
MESOTHELIOMA
COLORECTAL
RENAL
SCLC
ESOPHAGEAL
OVARIAN
Number of Clinical Trials
Broad global clinical program with more than 500 studies (largest PD-1/PD-LI program)
UROTHELIAL
PMBCL
NPC
ANAL
Updated 02-Mar-2017; source: clinicaltrials.gov
KEYTRUDA Provides Meaningful Benefit to Patients with Non-Small Cell Lung Cancer in Combination with Traditional Chemotherapy
ORR nearly doubled with KEYTRUDA combo vs. chemo alone
47% risk reduction of disease progression Median PFS = 13.0 Months
Adapted from presentation by C. Langer, ESMO 2016
Adapt
Innovate
Execute
Pursue the most promising science to address significant unmet medical
needs
Prioritize resources to high-growth areas, key markets and
customers
Develop culture and business model that evolve with internal and external
landscape
Committed to Being the Premier Research-Intensive Biopharmaceutical Company
Total Shareholder Returns (TSRs) Cumulative Returns as of December 30, 2016
Peer Avg Merck
Peers: AbbVie (1y, 3y), Amgen, Astra, BMS, GSK, J&J, Lilly, Novartis, Pfizer, Roche, Sanofi Source: Bloomberg (TSR based on actual closing prices)
5 Year
74.3%
85.7%
3 Year
14.5%
29.5%
1 Year
-4.0%
15.1%
We’ve Continued Strong R&D Investment $U
SD B
illio
ns $6.5B $6.6B $6.8B
$0.00$1.00$2.00$3.00$4.00$5.00$6.00$7.00$8.00$9.00
2014 2015 2016
Merck R&D Investment (non-GAAP)
Engaged in Critical Policy Efforts Top Policy Priorities • Sustainable pricing and
access to medicines & vaccines
• Innovation and intellectual property protection
• Comprehensive tax reform (U.S.)
Trump Calls for Deep Cuts in Business Taxes, Changes for Individuals
Donald Trump’s Economic Team Unveils Its Ambitious Plan for Tax Reform
Trump plan to slash business taxes to test Congress on deficit
House Passes Measure to Repeal and Replace the Affordable Care Act
House Passes Obamacare Repeal in Razor-Thin GOP Victory
RIVER BLINDNESS ALSO ELIMINATED IN
Colombia, Ecuador Guatemala, Mexico
LYMPHATIC FILARIASIS NOW ELIMINATED IN
Togo
Celebrating 30 Years:
MECTIZAN®
DONATION PROGRAM
Improved access to care to more than 6 million women 90 partners, 50 programs, 30 countries