Biogen Falls on Concerns Regarding Tecfidera Sales and PML Case – Analyst Blog

Despite posting better-than-expected earnings, Biogen Idec's ( BIIB ) shares fell 5.4% immediately after the release of third quarter results. Although shares recovered slightly in the subsequent trading session, the overall decline is approximately 3.3% since the announcement of third quarter results. The decline in share price reflects concerns regarding the growth prospects of Biogen's oral multiple sclerosis (MS) treatment, Tecfidera.

CEO Confirms PML Case on Call

Tecfidera, approved in the U.S. in Mar 2013 and the EU in Feb 2014, is one of Biogen's most successful product launches. Tecfidera, which is the number one oral MS treatment in the U.S., has already brought in sales of $1.99 billion so far this year and the company estimates that Tecfidera's market share in the U.S. at the end of the third quarter was in the high-teens.

However, third quarter Tecfidera sales lagged estimates and the growth rate is showing signs of slowing down. Moreover, concerns regarding the product's future have materialized with Biogen's CEO confirming a case of progressive multifocal leukoencephalopathy (PML) in a patient on Tecfidera.

On the company's third quarter call, Biogen said that the patient recently died from complications of pneumonia. The patient was on Tecfidera for 4.5 years as part of the ENDORSE study and had experienced severe lymphopenia that lasted for more than 3.5 years. The company pointed out that lymphopenia is a known risk factor for PML and can be caused by several factors including treatments for MS, cancer and HIV.

While Tecfidera's label already includes warnings and precautions regarding lymphopenia, Biogen has informed regulatory authorities about the case. Tecfidera has so far been used in more than 100,000 patients.

Our Take

PML (a rare, serious progressive neurologic disease which is often fatal) is a dreaded word where MS treatments are concerned and Biogen already has a history with PML with one of its MS drugs, Tysabri. Tysabri was withdrawn from the market in 2005 following confirmed cases of PML. However, it was back on the market in 2006 with stricter monitoring plans and went on to bring in significant revenues. So far in 2014, Tysabri sales are almost $1.5 billion.

We believe that, for now, more stringent patient monitoring rules may be implemented for prescribing Tecfidera. We do not expect Tecfidera scrips to be significantly impacted. With one case being reported out of more than 100,000 patients, patients may be willing to overlook safety concerns given Tecfidera's impressive efficacy.

Biogen is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the biotech sector include Medivation Inc. ( MDVN ), PDL BioPharma ( PDLI ) and Merrimack Pharmaceuticals, Inc. ( MACK ). All three are Zacks Rank #1 (Strong Buy) stocks.

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Biogen Falls on Concerns Regarding Tecfidera Sales and PML Case - Analyst Blog