Please ensure Javascript is enabled for purposes of website accessibility

What's Worrying Me About Biogen

By Todd Campbell - Apr 28, 2017 at 2:20PM

You’re reading a free article with opinions that may differ from The Motley Fool’s Premium Investing Services. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. Learn More

Biogen could struggle to maintain its market-leading position in multiple sclerosis over the next two years.

Biogen Inc. (BIIB -0.29%) recently reported its first-quarter financial results, and while the company remains the market share leader in multiple sclerosis (MS) treatment, there are signs that its dominance could be waning.

An increasingly competitive market

MS is a central nervous system disorder that can cause muscle weakness, blurred vision, and numbness. Patients are typically diagnosed with MS while they're in their 20s or 30s, and there currently isn't a cure.

A worried businessman.

IMAGE SOURCE: GETTY IMAGES.

Roughly 10,000 new cases of MS are diagnosed in the U.S. every year, and the total patient population worldwide is about 2.5 million. Because MS is a chronic condition, patients receive treatment for it throughout their lifetime, and that translates into a lot of prescriptions written annually for MS drugs. Currently, the MS market is worth about $20 billion per year, and Biogen is the largest player, with about a 38% market share.

Altogether, Biogen markets $3 billion blockbuster MS drugs, including the company's best seller, Tecfidera, an oral MS drug that posted first-quarter sales of $958 million. Its other drugs include Avonex and Tysabri, which generated sales last quarter of $537 million and $545 million, respectively, and it also markets Plegridy, a long-lasting formulation of Avonex that brought in first-quarter sales of $112 million.

The bright spot in Biogen's first-quarter results is that sales of Tysabri increased 14% year over year. Biogen's other drugs, however, didn't perform nearly as well. Tecfidera's sales were up only 1% and Avonex's sales fell 5%.

Lackluster top-line growth for Tecfidera is particularly concerning. In the past, Biogen's sales have benefited from both increasing volume and higher prices. Recently, pushback on pricing has crimped Biogen's pricing power, making it more reliant on new prescriptions. Those new prescriptions, though, are getting harder to come by.

Oral MS drugs are unquestionably the best in terms of treatment choices, but Tecfidera's not the only oral option. Novartis sells Gilenya and Sanofi sells Aubagio, and based on sales growth last quarter, Tecfidera appears to be losing ground to them. For perspective, Gilenya sales increased 3.4% to $722 million and Aubagio's revenue grew 29.7% to $371 million in Q1.

In discussing its first-quarter performance, Biogen estimated that lower inventory levels in the U.S. weighed down Tecfidera's sales. It also indicated that demand could be feeling some negative impact from the recent Food and Drug Administration approval of Roche's Ocrevus, the only approved medicine for treating both relapsing and primary progressive MS. Biogen's management admitted that there could have been some warehousing of patients ahead of Ocrevus' approval in late March. If so, then Ocrevus' toll on Biogen's market share could get bigger as its launch gains momentum.

Some headwinds for Biogen's MS market share due to Ocrevus will be offset by the fact that Roche owes Biogen royalties on Ocrevus sales. However, those royalties cap out at 30%, so they won't make up all the potential damage.

Importantly, Ocrevus isn't the only new drug that could dent Biogen's MS dominance. Recently, Celgene (CELG) reported compelling phase 3 data for its oral MS drug, ozanimod, and results from a second confirmatory phase 3 trial are expected soon. If results are good, then Celgene could file for ozanimod's approval later this year, clearing the way for an FDA OK by the end of 2018. Because ozanimod is an oral drug that works similarly to Gilenya (but is more selective), ozanimod could have billion-dollar blockbuster potential.

Looking ahead

It's not all bleak for Biogen. The company recently launched Spinraza, the first FDA-approved therapy for spinal muscular atrophy, and $47 million in Q1 sales suggests it's off to a fast start. The company's also got some intriguing drugs in the pipeline, including treatments for Alzheimer's disease. However, Spinraza's growth may end up simply offsetting sliding MS revenue, and Alzheimer's disease drugs have a high clinical trial failure rate, so it's too early to bank on them.

Overall, growing competition makes me think this could be a tough couple of years to be a Biogen investor.  

Todd Campbell owns shares of Celgene. His clients may have positions in the companies mentioned. The Motley Fool owns shares of and recommends Biogen and Celgene. The Motley Fool has a disclosure policy.

Invest Smarter with The Motley Fool

Join Over 1 Million Premium Members Receiving…

  • New Stock Picks Each Month
  • Detailed Analysis of Companies
  • Model Portfolios
  • Live Streaming During Market Hours
  • And Much More
Get Started Now

Stocks Mentioned

Biogen Inc. Stock Quote
Biogen Inc.
BIIB
$217.56 (-0.29%) $0.64
Sanofi Stock Quote
Sanofi
SNY
$49.08 (-1.27%) $0.63
Roche Holding AG Stock Quote
Roche Holding AG
RHHBY
$41.36 (0.49%) $0.20
Celgene Corporation Stock Quote
Celgene Corporation
CELG
Novartis AG Stock Quote
Novartis AG
NVS
$85.94 (0.43%) $0.37

*Average returns of all recommendations since inception. Cost basis and return based on previous market day close.

Related Articles

Motley Fool Returns

Motley Fool Stock Advisor

Market-beating stocks from our award-winning analyst team.

Stock Advisor Returns
377%
 
S&P 500 Returns
123%

Calculated by average return of all stock recommendations since inception of the Stock Advisor service in February of 2002. Returns as of 08/09/2022.

Discounted offers are only available to new members. Stock Advisor list price is $199 per year.

Premium Investing Services

Invest better with The Motley Fool. Get stock recommendations, portfolio guidance, and more from The Motley Fool's premium services.