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What to Expect from Merck & Bristol-Myers' IO Drugs in Q3?

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Among the myriad diseases and therapeutic areas covered by pharma and biotech companies, cancer will more often than not top the list of treatments being developed by most of these companies. This is not surprising if you take into account the statistics surrounding cancer.

According to the World Health Organization (WHO), cancers are among the leading causes of morbidity and mortality worldwide, with about 14 million new cases and 8.2 million cancer related deaths in 2012. Moreover, cancer cases are expected to rise from 14 million annually in 2012 to 22 million within the next two decades.

Given these numbers, it is no wonder that cancer is a key therapeutic focus area for most drug companies. These stocks are working on bringing innovative treatments to market with focus on targeted as well as breakthrough therapies on the rise.  

Among the newer treatments, cancer immunotherapy or immuno-oncology (IO) is a hot therapeutic area that has been garnering a lot of interest and activity from both large as well as small/mid-sized pharma and biotech companies. These treatments hold huge commercial potential and have the ability to change the treatment paradigm.

The basic concept is to utilize certain parts of the immune system to fight the disease. This can be done by stimulating the immune system to attack cancer cells or immune system components may be introduced into the body. While some IO treatments have the potential to be effective as monotherapies, others may be more effective when combined with other treatments.

Different types of immunotherapies include monoclonal antibodies/mAbs (man-made versions of immune system proteins which can be designed to attack a very specific part of a cancer cell), immune checkpoint inhibitors (recognize and attack cancer cells), vaccines (help prevent or treat cancer) and others that boost the overall immune system.

This week, a couple of companies with IO treatments in their portfolios will be reporting third quarter results. Here is a look at what to expect from these drugs.

New York-based Bristol-Myers Squibb Company (BMY - Free Report) will be announcing results on Oct 27. Opdivo, approved for different types of cancer (previously treated advanced non-small cell lung cancer (NSCLC), metastatic melanoma, previously treated advanced renal cell cancer, classical Hodgkin lymphoma) has a strong position in the second-line setting and has already brought in sales of more than $1.5 billion in the first half of the year. The drug is doing well in the lung and renal cell cancer settings. While sales will continue to grow, a slowdown is expected given the rapid initial uptake. Competition is also increasing -- Roche’s (RHHBY - Free Report) cancer immunotherapy, which was earlier approved for advanced bladder cancer, recently gained FDA approval for previously treated metastatic NSCLC.

Bristol-Myers’ other cancer immunotherapy, Yervoy, will remain under pressure due to the presence of PD-1 agents in international markets. However, the Opdivo-Yervoy combination for metastatic melanoma should continue doing well in the U.S.

BRISTOL-MYERS Price, Consensus and EPS Surprise

Kenilworth, NJ-based Merck & Co., Inc. (MRK - Free Report) will be reporting third quarter results on Oct 25. Merck’s anti-PD-1 therapy, Keytruda, is one of the most important recent product launches for the company. Keytruda, approved for use in different types of cancer settings (NSCLC, advanced melanoma, head and neck squamous cell cancer), brought in sales of $563 million in the first half of 2016. The treatment should see continued strength in the melanoma and second-line lung cancer settings.

Merck is currently working on expanding Keytruda’s label and recently reported that Keytruda met the primary endpoint of overall survival in a late-stage study for previously treated advanced bladder cancer -- an independent Data Monitoring Committee (DMC) recommended that the study should be stopped early.

Meanwhile, Keytruda sales should pick up significantly if it gains FDA approval for the first-line advanced NSCLC setting – a positive response from the FDA by Dec 24, 2016 would give the company a major head-start over Opdivo which failed to meet the primary endpoint in a late-stage study in treatment-naïve advanced NSCLC patients.

MERCK & CO INC Price, Consensus and EPS Surprise

Merck is a Zacks Rank #2 (Buy) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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