Merck Reports Q2 2020 Financial Results: Global Sales of $10.9 Billion, Keytruda Reaches $3.4 Billion

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MSD recently released its financial report for the second quarter of 2020:Global sales reached $10.9 billion, a year-on-year decrease of 8%., global sales decreased by 5% excluding the impact of foreign exchange.Pharmaceutical business revenue amounted to $9.7 billion, a year-on-year decrease of 7%.; Excluding the adverse impact of foreign exchange, sales decreased by 6%.

The primary reason for the decline in pharmaceutical sales was the negative impact of the pandemic on vaccines and hospital acute care products, along with the ongoing effects of lost market exclusivity for certain products, which were partially offset by strong growth in the oncology business.

In the oncology business,Keytruda’s sales amounted to $3.4 billion, representing a 29% increase., primarily driven by the continued strong momentum of non-small cell lung cancer (NSCLC) indications, along with sustained uptake in other indications, including adjuvant treatment for melanoma, renal cell carcinoma, bladder cancer, head and neck cancer, and microsatellite instability-high (MSI-H) cancers. Higher collaboration revenues related to Lynparza and Lenvima also contributed to the growth of the oncology business, reflecting ongoing market penetration of approved indications in the United States, Europe, and China.

Merck has narrowed and raised its full-year 2020 revenue guidance to $47.2–$48.7 billion, with an approximate 2% negative foreign exchange impact; it has also narrowed and raised its full-year 2020 GAAP EPS guidance to $4.58–$4.73 and its non-GAAP EPS guidance to $5.63–$5.78, with an approximate 3% negative foreign exchange impact.

The following are MSD’s pipeline highlights for the second quarter:

(1) Highlights of COVID-19-related research:

——V590：In collaboration with IAVI, we are developing a COVID-19 vaccine based on the recombinant vesicular stomatitis virus (rVSV) platform, which is the same platform used in MSD’s approved Ebola virus vaccine. Currently, V590 is in preclinical development, with clinical studies expected to commence this year.

——V591：Acquisition of Themis to Accelerate Development of a Measles Virus Vector-Based COVID-19 Vaccine, Initially Developed by Scientists at the Pasteur Institute and Exclusively Licensed to Themis. V591 is Currently in Preclinical Development, with Clinical Trials Expected to Launch in the Third Quarter.

——MK-4482：An oral antiviral drug co-developed with Ridgeback Bio for the treatment of COVID-19. In preclinical studies, the drug demonstrated antiviral activity against multiple viruses, including SARS-CoV-2 and the coronaviruses responsible for MERS and SARS. The drug is currently in Phase II clinical trials.

——Others:MSD is collaborating with the Institute for Systems Biology (ISB) to investigate and identify the molecular mechanisms of SARS-CoV-2 infection and COVID-19, as well as to identify drug and vaccine targets. Meanwhile, it has joined the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership led by the U.S. National Institutes of Health (NIH).

(2) Oncology Pipeline Highlights:

——Keytruda：Achieved multiple regulatory milestones, including four approvals from the U.S. FDA, one approval from China’s NMPA, and acceptance of three sBLAs by the U.S. FDA (two under priority review and one under standard review).

——Lynparza：The PARP inhibitor co-developed with AstraZeneca has also achieved multiple regulatory milestones, including two approvals from the U.S. FDA and one approval from the European Commission (EC).

——Lenvima：Multi-kinase inhibitor developed in collaboration with Eisai has achieved multiple clinical advancements: The Keytruda + Lenvima regimen demonstrated robust efficacy data as first-line treatment for hepatocellular carcinoma (HCC) and for the treatment of immune checkpoint inhibitor-refractory clear cell renal cell carcinoma. From a regulatory perspective, the supplemental Biologics License Application (sBLA) for this regimen as first-line treatment for HCC received a Complete Response Letter from the FDA. This decision was based on the fact that Roche’s Tecentriq + Avastin combination has already been approved for first-line treatment of HCC with demonstrated overall survival benefit, and current evidence does not support that the Keytruda + Lenvima regimen offers a meaningful advantage over the Roche combination.

——MK-6482：Hypoxia-Inducible Factor-2α (HIF-2α) Inhibitor: First Announcement of Phase II Clinical Trial Results Demonstrates Durable Response in Von Hippel-Lindau (VHL) Syndrome-Associated Clear Cell Renal Cell Carcinoma (ccRCC), with a Confirmed Objective Response Rate of 27.9% and Median Duration of Response Not Yet Reached. Recently, the Drug Received Breakthrough Therapy Designation from the U.S. FDA.

(3) Highlights of the Vaccine Pipeline:

——V114：The investigational 15-valent pneumococcal conjugate vaccine achieved success in two adult Phase III studies, PNEU-WAY (V114-018) and PNEU-FLU (V114-021), meeting their safety and immunogenicity endpoints.

——GARDASIL 9：Recombinant Human Papillomavirus 9-Valent Vaccine, Approved by the U.S. FDA for the Prevention of Oropharyngeal Cancer and Other Head and Neck Cancers Caused by Seven High-Risk HPV Types (16, 18, 31, 33, 45, 52, 58)

(4) Other Pipeline Highlights:

——vericiguat：First-in-class oral sGC stimulator co-developed with Bayer receives Priority Review from the U.S. FDA for its New Drug Application; used in combination with other heart failure medications to reduce the risk of cardiovascular death and heart failure hospitalization following worsening heart failure events in patients with symptomatic chronic heart failure with reduced ejection fraction.

——islatravir：New analysis data from the Phase IIb study of an investigational oral nucleoside reverse transcriptase translocation inhibitor (NRTTI) in combination with doravirine as first-line treatment for adults with HIV-1 infection have been released. The 48-week data further support the efficacy and safety of this two-drug regimen as first-line therapy for HIV-1 infection.

——Recarbrio：Novel Combination Antibiotic Product Receives FDA Approval for a New Indication: Treatment of Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia in Adults Aged 18 Years and Older

Reference: Merck Announces Second-Quarter 2020 Financial Results