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MarketScreener Homepage  >  Equities  >  Nyse  >  Merck & Co., Inc.    MRK

MERCK & CO., INC.

(MRK)
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Merck : Merk Oncology Overview ESMO 2020 Presentation

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09/22/2020 | 01:20pm EDT

Merck

Oncology Overview

ESMO 2020

Forward-looking statement

This presentation 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).

2

Extensive new data at ESMO further highlights how we are executing on a broad oncology strategy to improve outcomes for cancer patients globally

Further establish

Broadly explore

Advance pipeline

Identify patients

KEYTRUDA as

combinations to

and pursue strategic

most likely to

foundational treatment

reach more patients

collaborations

benefit using

and advance into earlier

and acquisitions to

biomarkers

stages of disease

expand portfolio

3

Comprehensive KEYTRUDA development program

4

We have an opportunity to shape the future by leveraging our robust portfolio and pipeline…

*Seattle Genetics collaboration expected to close in third quarter.

5

ESMO 2020: New, long-term and early data from broad portfolio

6

KEYNOTE-590: new KEYTRUDA data in 1L esophageal cancer in combination with chemotherapy demonstrated superior overall survival and progression-free survival compared to chemotherapy

KEYTRUDA plus chemotherapy reduced risk of death by 27% compared to chemotherapy as 1L treatment for patients with metastatic esophageal cancer, regardless of histology or PD- L1 expression status

First anti-PD-1 therapy in combination to show superior OS, PFS and ORR compared to chemotherapy, regardless of histology

7

LEAP-004: KEYTRUDA + LENVIMA in stage III melanoma introduces potential new treatment for PD-1/L1 refractory patients

LENVIMA in combination with KEYTRUDA showed antitumor activity in patients with advanced melanoma with confirmed progression on a PD-1/L1 inhibitor

• 21.4% BICR-confirmed ORR by RECIST v1.1 in total population

• 31.0% BICR-confirmed ORR in patients with PD on prior anti-PD-1/L1 + anti-CTLA-4

• 13.9-month median OS

8

Long-termfollow-up data confirm durable OS benefits of KEYTRUDA monotherapy in combination with chemo or as adjuvant following surgery

Long-termfollow-up data for LYNPARZA demonstrates OS benefit in BRCA1/2- or ATM-mutated mCRPC and PFS in BRCAm advanced ovarian cancer

Vibostolimab (TIGIT): first-time data from cohort expansion in patients with advanced NSCLC naïve to anti-PD-1/L1 therapy show compelling response rates

Vibostolimab is a monoclonal antibody that inhibits the T-Cell checkpoint inhibitor TIGIT

Vibostolimab in combination with KEYTRUDA showed compelling response rates in NSCLC patients naïve to anti-PD- 1/L1 therapy

Combination showed 29% (12/41) ORR in all enrolled PD-1/L1 naïve patients and;

• TPS>1% ORR 46%

• TPS<1% ORR 25%

Moving to Phase 3 NSCLC in 2021

Additional exploratory studies across multiple other indications

11

MK-4830 (ILT4): first-time initial efficacy data from Phase 1 dose escalation study shows potential for asset in solid tumors

ILT4 preliminary efficacy data showed an ORR of 24% (8/34) in patients who received MK-4830 in combination with KEYTRUDA

Among 11 patients who progressed on prior PD-1 therapy, there were 5 responses (45%)

Phase 2 umbrella studies in

NSCLC under way

Data cutoff: July 10, 2020

12

MK-6482(HIF-2α): updated data on VHL-associated cRCC and non-RCC disease shows promising overall response rates

Promising clinical activity was observed with MK- 6482 in treatment-naive patients with VHL- associated RCC

  • Confirmed ORR, 36.1 % (95% CI, 24.2-49.4);
    7 other patients (11.5%) experienced unconfirmed PR
  • Median DOR, not yet reached; 91.8% of patients remain on study therapy

Clinical activity was also observed in non-RCC lesions

  • In pancreatic lesions, confirmed ORR, 63.9% (95% CI,50.6-75.8)
  • In CNS hemangioblastomas, confirmed ORR, 30.2% (95% CI, 17.2-46.1)

In retinal lesions, 93.8% of patients had a best response of improved or stable

Areas of the Body Affected by von Hippel-Lindau Disease

Benign Tumors

Advanced/Malignant Tumors

CNS Hemangioblastoma (70-80%)

RCC (25-60%)

• Retinal Hemangioblastoma (50-60%)

Pheochromocytoma (10-20%)

Pancreatic Cyst and Cystadenoma (50%)

Pancreatic NET (10-20%)

  • Endolymphatic Sac Tumor of the middle ear (10-25%)
  • Tumor of the Epididymis or Broad Ligament (10-60%)

13

We have pursued collaborations, licensing agreements, and acquisitions that will increase our ability to provide benefit to cancer patients

* Indicates strategic collaboration

14

Q&A

To ask a question on the operator-assisted audio line, press *1.

Note: be sure to mute your computer speakers if you are listening to the audio webcast.

15

Appendix

16

KEYTRUDA has now demonstrated activity in more than 30 different types of cancer defined by site of origin, histology, or genetic markers

KEYTRUDA monotherapy and in combination improved overall survival in Phase 3 studies across a broad range of malignancies

18

KEYTRUDA is being explored in a broad adjuvant program with 20 registrational studies ongoing

2018

2019

2020

2021

2022

2023

2024

2025

2026+

Adjuvant

TNBC

cSCC Locally

HNSCC Adjuvant

Adjuvant

Gastric &

NSCLC

Neo/adjuvant

TNBC Adjuvant

Melanoma

Neoadjuvant /

Advanced

(KEYNOTE-412)

Melanoma

Esophageal

Neoadjuvant

MIBC

(KEYNOTE-242)

(KEYNOTE-054)

Adjuvant

(KEYNOTE-629)

(KEYNOTE-716)

Adjuvant /

(KEYNOTE-671)

(KEYNOTE-866)

APPROVED

(KEYNOTE-522)

APPROVED in

NSCLC Adjuvant

Neoadjuvant

cSCC Locally

pCR presented,

recurrent or

(KEYNOTE-091)

RCC Adjuvant

(KEYNOTE-585)

Neo/adjuvant

Advanced

File under review

metastatic

(KEYNOTE-564)

MIBC

(KEYNOTE-630)

HNSCC Adjuvant

(KEYNOTE-905)

ER+ / HER2-

/ Neoadjuvant

(KEYNOTE-689)

NSCLC Stage

Breast Cancer

I/IIa

Adjuvant /

(KEYNOTE-867)

Neoadjuvant

(KEYNOTE-756)

HCC Adjuvant (KEYNOTE-937)

Ovarian BRCAwt + chemo (KEYLYNK-001)

Timeline based on clinicaltrial.gov primary completion dates. Actual timing may vary.

19

Extensive KEYTRUDA+LYNPARZA combination (KEYLYNK) and LYNPARZA monotherapy programs

1L, nonBRCA, KEYTRUDA combo (KEYLYNK-001)

1L Maintenance BRCA+ (SOLO-1) - Approved

1L Maintenance, All Comers Combo + Bevacizumab (PAOLA-1)-

Approved in HRD positive

PSR, All Comers Combo + Cediranib (GY004)

PRR, All Comers Combo + Cediranib (GY005)

2L+ PSR (SOLO2/Study19 ) - Approved

  • mCRPC, All Comers (KEYLYNK-010)
  • mCRPC, HRRm (PROfound) - Approved
  • mCRPC, All Comers Combo + Abiraterone (PROpel)

Prostate

cancer

Tumor

Agnostic

Tumor

agnostic

Lung

Lung

HRRm/HRD Basket (KEYLYNK-007)

cancer

Cancer

HRRm Basket (LYNK-002)

3L+ PSR, gBRCA Treatment (SOLO3)

Breast cancer

Ovarian cancer

TNBC (KEYLYNK-009)

Pancreatic

1L NSQ NSCLC (KEYLYNK-006)

1L SQ NSCLC (KEYLYNK-008)

cancer

Stage III NSCLC (KEYLYNK-012)

  • 1L Maintenance gBRCA (POLO) - Approved
  • mBC, gBRCA (OlympiAD) - Approved
  • HER2- Adjuvant, gBRCAm (OlympiA)

Collaboration with AstraZeneca

20

PRR: Platinum Relapsed Recurrent; PSR: Platinum Sensitive Recurrent

Extensive KEYTRUDA+LENVIMA combination (LEAP) and LENVIMA monotherapy programs

1L EC (LEAP-001)

2L EC (Study 309 / KN-775)

2L EC (KEYNOTE-146) -

1L PD-L1+ HNSCC

1L NSQ Combo with KEYTRUDA

(LEAP- 010)

and Chemo (LEAP-006)

1L PD-L1+ NSCLC (LEAP-007)

Head & neck

2L NSQ (LEAP-008)

cancer

Urothelial

cancer

Lung

cancer

Basket

trial

TNBC

Gastric

Ovarian

1L RCC Combo with Evero or

Approved

Melanoma

1L UC (LEAP-011)

Colorectal

KEYTRUDA (KN-581 / Study 307)

Glioblastoma

  • 2L RCC Combo with Evero (Study 205) - Approved

Endometrial

carcinoma

Biliary

  • 1L Thyroid - Approved

Thyroid cancer

Renal cell carcinoma

Hepatocellular

1L Melanoma (LEAP-003)

2L Melanoma (LEAP-004)

carcinoma

  • 1L HCC Combo (LEAP-002)
  • 1L HCC Combo/TACE (LEAP-012)
  • 1L HCC Mono (Study 304) - Approved

Registrational studies only

21

Collaboration with Eisai

Early oncology pipeline* includes more than 20 investigational immuno-therapeutic candidates - including novel combinations with KEYTRUDA

*Select compounds only

Disclaimer

Merck & Co. Inc. published this content on 21 September 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 22 September 2020 16:19:02 UTC


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Financials (USD)
Sales 2020 48 046 M - -
Net income 2020 11 880 M - -
Net Debt 2020 15 814 M - -
P/E ratio 2020 16,7x
Yield 2020 3,11%
Capitalization 197 B 197 B -
EV / Sales 2020 4,43x
EV / Sales 2021 4,10x
Nbr of Employees 71 000
Free-Float 70,6%
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Kenneth C. Frazier Chairman, President & Chief Executive Officer
Robert M. Davis CFO & Executive Vice President-Global Services
Sandy Tremps Vice President-R&D IT CIO
Thomas Henry Glocer Independent Director
Leslie A. Brun Lead Independent Director
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