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MERCK & CO., INC.

(MRK)
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Merck : 2Q21 Merck Earnings Presentation

07/29/2021 | 07:17am EDT

Merck

Q2 2021 Earnings

Forward-looking statement of Merck & Co., Inc.,

Kenilworth, N.J., USA

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 2020 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

Q2 performance highlights

Invested $2.5B in research and development, making

Created

Worldwide

$11.4B

significant progress in advancing our pipeline and

shareholder

sustaining our key growth pillars

value

sales

Returned $1.9B to shareholders through dividends and

+19%

share repurchase

performance1,4

Completed spinoff of Organon on June 2, received cash

distribution of approximately $9B

FDA approved 4 filings in oncology and vaccines and granted 2

priority reviews in oncology

Advanced

Non-GAAP

$1.31

In the EU, received 2 approvals for KEYTRUDA and one

In China, received 2 approvals in oncology

the

EPS

approval for Verquvo

+27%

Presented data at ASCO, ESMO Virtual Plenary, ECCMID, and

pipeline5

performance1,4

IAS

Toplined results for KEYTRUDA and VAXNEUVANCE

Advanced COVID-19 antiviral into 2 Phase 3 trials

  1. Growth rates exclude impact of foreign exchange
  2. The GAAP to non-GAAP reconciliation is available in the Supplemental Tables to Merck's Q2 2021 earnings release.

3. GAAP EPS =$0.48

3

4. Results are presented on a continuing operations basis

5. Key milestones through July 29, 2021

Driving value for patients and shareholders by progressing our pipeline

Key regulatory milestones through July 29:

  • In the U.S., received approval for KEYTRUDA in high-riskearly-stage TNBC based on KN-522, in gastric or GEJ cancer based on KN-811, in endometrial cancer based on KN-775, and in locally advanced cSCC based on KN-629, as well as received approval for pneumococcal conjugate vaccine VAXNEUVANCE (V114) in adults
  • In the U.S., FDA granted priority reviews for KEYTRUDA + Lenvima in RCC based on KN-581
  • In the EU, received approval for Verquvo in certain patients with chronic heart failure, and approval for KEYTRUDA in certain types of esophageal or GEJ cancer based on KN-590, as well as approval for an alternative dosing regimen for KEYTRUDA, dosing patients once every six weeks for combination therapies
  • In China, received approval for KEYTRUDA in dMMR/MSI-H CRC based on KN-177 and Lynparza in certain types of advanced prostate cancer based on PROfound

Key data presentations through July 29:

  • Presented new data from KEYNOTE-522 in neoadjuvant and adjuvant TNBC at ESMO Virtual Plenary 2021
  • Presented data across our broad oncology portfolio at ASCO, including for KEYTRUDA (KN-564,KN-811,KN-581, and KN-775) and Lynparza (OlympiA), as well as first-time Phase 1 data for favezelimab (MK-4280) in MSS CRC and updated Phase 2 data for belzutifan (MK-6482)
  • Presented pivotal data (PNEU-AGE) and additional Phase 3 data (PNEU-AGE,PNEU-TRUE,PNEU-PATH, and PNEU-DAY) for VAXNEUVANCE (V114) at ECCMID
  • Presented Phase 2a data for once-monthly islatravir in HIV PrEP and Phase 2 islatravir safety analysis data in HIV treatment at IAS
  • Toplined results for KEYTRUDA as part of a combination regimen in certain patients with advanced TNBC (KN- 355) and in patients with advanced cervical cancer (KN-826) and VAXNEUVANCE (V114) in the pediatric setting (PNEU-DIRECTION and PNEU-PLAN)
  • Advanced COVID-19 antiviral, molnupiravir (MK-4482), into Phase 3 pivotal trial in the high-risk outpatient setting, presented efficacy data from inpatient and outpatient Phase 2 studies at ECCMID and initiated Phase 3 trial in the post-exposure prophylaxis setting

4

Broad and innovative pipeline to solve significant unmet medical needs

Phase 2

Phase 3

Under regulatory review

Oncology

Oncology

Oncology

KEYTRUDA (MK-3475)

MK-2140

V937

MK-1308A

KEYTRUDA (MK-3475)

LENVIMA (MK-7902)

Belzutifan (MK-6482)

Advanced Solid Tumors

Breast

Melanoma

Advanced Solid Tumors

Biliary Tract

Bladder

VHL-aRCC (US)

LYNPARZA (MK-7339)

NSCLC

Breast

HCC

Cervical (EU)

Melanoma

KEYTRUDA (MK-3475)

CSCC

CRC

NSCLC

Advanced Solid Tumors

MK-4280

HNSCC

Melanoma

cSCC (EU)

HNSCC

MSI-H Endometrial

MK-6440

NSCLC

Solid Tumors

Gastric (EU)

Gastric

TMB-H (JPN)

Breast

Hematological Malignancies

MK-7684

MK-1308

Hepatocellular (EU)

Colorectal

Unresectable or Metastatic MSI-H or dMMR Colorectal (JPN)

NSCLC

NSCLC

Metastatic TNBC (EU, JPN)

MK-4280A

Melanoma

Mesothelioma

LYNPARZA (MK-7339)

Adjuvant RCC (EU)

SCLC

TUKYSA (MK-7119)

Ovarian

HNSCC

RCC

MK-5890

NSCLC

Advanced Unresectable Metastatic Esophageal (JPN)

Esophageal

Advanced Solid Tumors

Prostate

SCLC

LENVIMA (MK-7902)

LENVIMA (MK-7902)

NSCLC

Colorectal

Gastric

SCLC

Colorectal

1L HCC (US)

Biliary Tract

Gastric

Prostate

Glioblastoma

MK-6482

Endometrial

MK-6482

Advanced unresectable RCC (US, EU, JPN)

Melanoma

Pancreas

VHL aRCC (EU)

NSCLC

MK-1308A

RCC

Advanced endometrial (EU, JPN)

MK-1026

MK-4830

Bladder

RCC

TUKYSA (MK-7119)

Vaccines

BTC

Hematological Malignancies

NSCLC

Cervical

MK-7684A

Breast

V114

SCLC

NSCLC

Pneumoconjugate Vaccine, adult (EU)

Vaccines

Neuroscience

Infectious diseases

General medicine

V160

MK-8189

MK-8591A (doravirine/islatravir)

Gefapixant (MK-7264)

Cytomegalovirus

Schizophrenia

HIV-1 Infection

Cough (US, JPN, EU)

V116

Infectious diseases

Islatravir (MK-8591)

Cubicin (MK-3009)

Pneumococcal, adult

MK-8591B(Islatravir/MK-8507)

HIV-1 Infection

cSST & Sepsis, pediatric (JPN)

V184

Molnupiravir (MK-4482)

Noxafil (MK-5592)

HIV-1 Infection

Chikungunya Virus

COVID-19

General medicine

Invasive aspergillosis (US, EU, Japan)

MK-1654

Respiratory Syncytial Virus

MK-7075

Cardiovascular

Overgrowth Syndrome

MK-1942

MK-5475

Treatment Resistant Depression

Pulmonary Arterial Hypertension

MK-3655

5

NASH

As of July 27, 2021

This is an excerpt of the original content. To continue reading it, access the original document here.

Disclaimer

Merck & Co. Inc. published this content on 29 July 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 29 July 2021 11:16:17 UTC.


© Publicnow 2021
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