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A Big Month Ahead for the FDA and Bristol-Myers Squibb

By Cory Renauer - Feb 22, 2020 at 6:37AM

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Success for the Celgene merger rests heavily on new drug approvals the U.S. Food and Drug Administration could deliver in March.

It's been a few months since Bristol-Myers Squibb (BMY 1.49%) completed its $74 billion purchase of Celgene, but investors still aren't sure if a couple of key assets that spurred the transaction will ever generate sales.

In March and early April, the FDA is expected to announce approval decisions for two new drugs that could eventually generate billions in annual revenue. Also, Bristol-Myers' successful cancer immunotherapy franchise could gain access to a new patient population.

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Image source: Getty Images.

If you're considering Bristol-Myers Squibb stock, it's probably best to see how the following three decisions play out first. Here's what to look for.

1. Ozanimod for multiple sclerosis

On or before March 25, the FDA will announce an approval decision regarding an oral treatment for patients with relapsing multiple sclerosis. Nearly two years ago, ozanimod was expected to become a new blockbuster multiple sclerosis (MS) treatment. Instead of a widely expected approval, though, the FDA kicked the application back because Celgene forgot to fill out some important sections.

The FDA began reviewing an updated new drug application for ozanimod last June and set an action date for March 25, 2020. During trials supporting ozanimod's application, patients treated with the drug experienced significantly less disease progression than those given standard care.

Solid trial results mean there's a very good chance the FDA will grant approval to ozanimod. Just how popular it will become in an increasingly competitive market for new multiple sclerosis treatments, though, is tough to predict.

Celgene had been predicting peak annual sales between $4 billion and $6 billion for ozanimod before Bristol-Myers made its offer. With increasing competition for a limited number of MS patients, though, investors might want to temper their expectations.

If approved, ozanimod will compete with an extremely popular new MS treatment from Roche called Ocrevus. Roche launched Ocrevus in 2017 and sales of the twice-annual infusion reached an astounding $3.8 billion in 2019. 

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Image source: Getty Images.

2. Reblozyl for myelodysplastic syndromes

Roughly 15,000 Americans are diagnosed each year with some form of myelodysplastic syndromes (MDS), and many of them require frequent blood transfusions because they can't produce enough red blood cells on their own. Reblozyl is a first-in-class red blood cell booster that earned approval to treat patients with beta-thalassemia in November, and it could soon become a new treatment for patients with anemia caused by myelodysplastic syndromes.

On or before April 4, 2020, the FDA will announce an approval decision regarding Reblozyl as a treatment for patients with MDS-driven anemia who rely on frequent blood transfusions. During trials underpinning the application under review, 38% of MDS patients treated with Reblozyl achieved eight weeks of transfusion independence compared to just 13% of patients treated with a placebo.

Before the acquisition, Celgene told investors future Reblozyl sales could reach $2 billion annually -- another approval to treat patients with MDS could go a long way toward reaching that estimate.

A rubber stamp that stamps FDA approved with a checkmark.

Image source: Getty Images.

3. Opdivo plus Yervoy for liver cancer

Earlier this year, Bristol-Myers withdrew an application to treat newly diagnosed lung cancer patients with its cancer immunotherapy combination, Opdivo plus Yervoy. Even though the important first-line lung cancer indication is probably out of reach, the pair of checkpoint inhibitors generated a whopping $8.1 billion in combined sales last year.

In 2020, the pair of treatments could continue growing at a rapid pace thanks to a potential label expansion to treat liver cancer patients who relapse after standard first-line treatment. The FDA is expected to announce an approval decision for Bristol-Myers' immunotherapy combination on or before March 10, 2020, and approval seems likely. During the CheckMate-040 study that's supporting the application under review, the combination therapy shrank tumors for 31% of patients.

The second-line liver cancer indication isn't nearly as large as the first-line lung cancer space that Opdivo has found so elusive, but it's still large enough to warrant attention. Each year, liver cancer claims the lives of around 27,000 Americans, and the number of new diagnoses is on the rise.

A good stock to buy?

Bristol-Myers shares have been trading at around 10.6 times forward earnings estimates, which is well below the S&P 500 average of 19.4 times estimates. Relatively steady profits from Opdivo, Yervoy, and blood thinner Eliquis could produce enough profit to provide market-beating returns. With a potential new MS blockbuster in ozanimod, and possible label expansions for Opdivo, Yervoy, and Reblozyl in the works, Bristol-Myers Squibb shares have a strong chance to outperform in the years ahead.

Cory Renauer has no position in any of the stocks mentioned. The Motley Fool owns shares of and recommends Bristol-Myers Squibb. The Motley Fool has a disclosure policy.

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