Johnson & Johnson (JNJ 0.66%) reported its fourth-quarter financials this week, and one of the bright spots in the quarter was ramping demand for Darzalex, the company's new multiple myeloma therapy. Will Darzalex be the next Johnson & Johnson drug to eclipse the billion-dollar sales mark?

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Targeting a big market

The multiple myeloma market is massive, and there's a big need for new treatments that can improve patient outcomes.

In the U.S., the National Cancer Institute estimates that there are over 30,000 new cases of myeloma annually, and the five-year survival rate is just 48.5%, despite some big advances in treatment over the past decade.

Perhaps the most significant advance in treatment so far has been Celgene Corp.'s (CELG) Revlimid. Over the past 10 years, Revlimid has become the most widely used second-line multiple myeloma therapy, and following an approval for first-line use in 2015, it's rapidly become the go-to in that setting, too.

Revlimid's efficacy -- coupled with a six-figure price tag -- has made it Celgene's top-selling medicine, with sales of more than $8 billion expected this year.

Darzalex isn't going to displace Revlimid's dominance in the indication anytime soon, but it is getting increasingly used in patients that have seen their disease return following Revlimid, and a recent label expansion means that it could see sales grow from being used in combination with it.

Initially, Darzalex won approval in November 2015 for use in patients who had received at least three prior treatments. That put Darzalex use behind the use of Revlimid and Pomalyst, another blockbuster Celgene drug that's approved for third-line treatment.

Despite the limited patient pool, Darzalex has become an important drug that can help patients who previously had few remaining treatment options. As a result, Darzalex sales totaled $572 million in 2016, its first full year on the market. 

Those sales could climb even more dramatically in 2017. That's because the FDA expanded Darzalex's label in November 2016 so that it can be used alongside Revlimid in patients that have already received just one prior therapy. The FDA also granted approval for Darzalex's use alongside Velcade in this patient setting.

Looking ahead

While Darzalex's sales were $572 million for the full-year 2016, sales increased significantly into the year's end following the FDA's decision.

In Q4, Darzalex's $200 million in revenue netted it an $800 million annualized sales run rate. If Darzalex sales increase sequentially by just $50 million in Q1, it will achieve a billion-dollar blockbuster sales pace.

Darzalex's fast growth is especially important to the company (and investors) because Johnson & Johnson faces growth headwinds this year. The company's top-selling drug, Remicade, began competing against biosimilars in the U.S. for the first time in November, and that competition could weigh down Remicade sales, which totaled $1.17 billion in Q4, down 1.7% year over year.