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Merck Banks on Keytruda, Pipeline & Deals Amid Generic Woes

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We issued an updated report on Merck & Co., Inc. (MRK - Free Report) on Oct 1, 2020.

Merck boasts more than six blockbuster drugs in its portfolio with PD-L1 inhibitor, Keytruda, approved for several types of cancer, alone accounting for more than 25% of its pharmaceutical sales. Keytruda has played an instrumental role in driving Merck’s steady revenue growth in the past two years

Keytruda is approved for use in 30 indications across several different tumor types in the United States. Keytruda is continuously growing and expanding into new indications and markets globally. Its sales are gaining particularly from strong momentum in the first-line lung cancer indication.

In fact, the Keytruda development program is also progressing well and the drug is being studied for more than 30 types of cancer in more than 1200 studies, including more than 850 combination studies. Merck is collaborating with several companies including Amgen (AMGN - Free Report) , Incyte, Glaxo and Pfizer separately for the evaluation of Keytruda in combination with other regimens. Several regulatory decisions for new indications in the United States as well as in Europe are pending in the next few months, which, if approved, can further boost sales.

Animal health and vaccine products remain core growth drivers at Merck. Though sales of its Animal Health products and vaccines like Gardasil have been hurt lately due to the impact of coronavirus, their sales are expected to recover in the second half as veterinarian offices have opened and wellness visits for vaccinations resume.

Merck has many pipeline candidates in advanced stages of development targeting multiple disease areas. Key candidates are V114, its 15-valent pneumococcal conjugate vaccine for which an NDA is expected to be filed later this year, and vericiguat for chronic heart failure with reduced ejection fraction, which is under review in the United States (PDUFA Date: Jan 20, 2021). A key FDA approval this year has been of Koselugo (selumetinib) for the treatment of pediatric patients with neurofibromatosis type 1 (NF1) related plexiform neurofibromas (PN), a rare and debilitating genetic condition. Meanwhile, Lynparza, which it markets in partnership with AstraZeneca (AZN - Free Report) , was approved for metastatic castration-resistant prostate cancer (with HRR genetic mutations) in May 2020, which marked the drug’s approval for the fourth cancer type.

Merck has also been on a strong footing in terms of collaborations activity this year. Merck announced three deals this year to find new antivirals and vaccines to help combat COVID-19. First, Merck acquired Austrian private biotech, Themis, in June. Themis has a COVID-19 vaccine candidate, V591, in preclinical development with clinical studies expected to start in the third quarter. Themis developed the candidate using its measles virus vector platform. Second, Merck is co-developing private biotech, Ridgeback Biotherapeutics’ oral antiviral candidate, MK-4482 (previously EIDD-2801), which is being evaluated in phase II studies for the treatment of COVID-19. Third, Merck in collaboration with a non-profit research organization, IAVI, is co-developing, V590, a vaccine to prevent COVID-19 using its rVSV platform, which was used to make its Ebola vaccine. V590 is in pre-clinical development with clinical studies expected to start this year.

Earlier this month, Merck announced an agreement to co-develop and co-commercialize Seattle Genetics’ antibody-drug conjugate ladiratuzumab vedotin, which is in mid-stage development for breast cancer and other solid tumors. In another oncology collaboration, Merck acquired an exclusive license to commercialize Seattle Genetics’ newly-approved breast cancer drug, Tukysa in Asia, the Middle East and Latin America besides other regions outside the United States, Canada and Europe.

However, generic competition for several drugs and rising competitive pressure, mainly on the diabetes franchise will continue to be overhangs on Merck’s top line. Also, sales of several of Merck’s medicines were hurt in the second quarter due to social distancing measures, fewer patient visits and delays in elective surgeries due to COVID-19. Mainly COVID-19 hurt sales of Bridion and Merck’s vaccines, including Gardasil. However, Keytruda continued to do well and provided top-line support.

Meanwhile, Merck said that the majority of the COVID-19 related negative impact occurred in the second quarter with a gradual recovery beginning toward the end of the quarter. Merck expects normal business operations to resume in the fourth quarter.

Overall, higher sales of drugs like Keytruda, Lynparza and Bridion, top-line support from animal health and vaccine products, potential pipeline successes, new product approvals and line extensions and cost savings should drive the stock, going forward.

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